ARCHIVED Authorized medical devices for uses related to COVID-19: List of products no longer authorized
Notice to Reader:
This is an archived page. Please refer to the current version of the List of medical devices no longer authorized.
On this page
What is included in this list
Authorizations may be revoked for some medical devices that were authorized under the:
- first interim order for importing and selling medical devices during COVID-19
- second interim order for importing and selling medical devices during COVID-19
- third interim order for importing and selling medical devices during COVID-19 or
- Part 1.1 of the Medical Devices Regulations (MDR)
Reasons for cancelling an authorization
As per section 68.21 of the MDR, the Minister may cancel the authorization for importing or selling a COVID-19 medical device if:
- the Minister has reasonable grounds to believe that:
- the authorization holder has contravened the Act or the Regulations
- the risks outweigh the benefits associated with the device having regard to
- the uncertainties relating to the benefits and risks and
- the UPHN or absence of UPHN for the device the risks
- the authorization holder does not have an adequate quality management system in place
- the health or safety of patients, users or other persons may be unduly affected by the device or
- the authorization holder failed to comply with the terms and conditions of the authorization
- the authorization for sale of a COVID-19 medical device that was issued by a foreign regulatory authority is suspended or cancelled
- the authorization holder does not submit additional information, documents or material to the Minister within the time limit specified in the request or
- the authorization holder does not meet additional requirements within the prescribed timelines after their medical device is no longer on the UPHN list
An authorization is cancelled when:
- the authorization holder of a Class I COVID-19 medical device has been issued an MDEL under Part 1 of the MDR
- the authorization holder of a Class II, III or IV COVID-19 medical device has been issued an MDL under Part 1 of the MDR or
- the authorization holder either informs the Minister that they are no longer selling the device in Canada or requests that the authorization be cancelled
We will implement compliance and enforcement measures if a COVID-19 medical device authorized for importation or sale under Part 1.1 of the MDR is in non-compliance.
For more information, please consult the following guidance document:
| Device name | Manufacturer | Authorization number | Date the notice of cancellation was issued | Reason for cancellation |
|---|---|---|---|---|
| COVID-19 IGG/IGM RAPID TEST DEVICE | ASSURE TECH. (HANGZHOU) CO. LTD. | 312782 | 2023-12-06 | The manufacturer is no longer marketing the device. |
| BIOMEDOMICS COV-SCAN RAPID ANTIGEN TEST & COVID-19 ANTIGEN EXTERNAL CONTROL KIT | BIOMEDOMICS, INC. | 331374 | 2023-12-06 | The manufacturer is no longer marketing the device. |
| 1COPY COVID-19 QPCR MULTI KIT | 1DROP INC. | 312777 | 2023-12-06 | The manufacturer is no longer marketing the device. |
| INSTI COVID-19 TEST CONTROLS | BIOLYTICAL LABORATORIES INC. | 327496 | 2023-12-06 | The manufacturer is no longer marketing the device. |
| PURITAN BENNETT 980 SERIES VENTILATOR | COVIDIEN LLC | 317667 | 2023-11-14 | License issued. |
| MCMASTER MOLECULAR MEDIUM (MMM) | BAY AREA HEALTH TRUSTEE CORP. DBA BAY AREA RESEARCH LOGISTICS | 336252 | 2023-11-14 | The manufacturer is no longer marketing the device. |
| VIRADX SARS-COV-2/FLU A+B RAPID ANTIGEN TEST | PRINCETON BIOMEDITECH CORP | 344266 | 2023-11-21 | The manufacturer is no longer marketing the device. |
| BD SARS-COV-2/FLU FOR BD MAX SYSTEM | BECTON DICKINSON AND COMPANY (BD) | 329166 | 2023-11-24 | The manufacturer is no longer marketing the device. |
| LUMIRADX SARS-COV-2 & FLU A/B RNA STAR COMPLETE | LUMIRADX UK LTD | 356762 | 2023-11-15 | The manufacturer is no longer marketing the device. |
| COVCLEAR COVID-19 RAPID ANTIGEN TEST | EMPOWERED DIAGNOSTICS, LLC | 330172 | 2023-10-26 | The manufacturer is no longer marketing the device. |
| BINAXNOW COVID-19 AG CARD | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 341746 | 2023-10-13 | The manufacturer is no longer marketing the device. |
| ANTI-SARS-COV-2 TOTAL ANTIBODY (AB) ELISA KIT | DIAGNOSTICS BIOCHEM CANADA INC. | 319720 | 2023-10-16 | The manufacturer is no longer marketing the device. |
| FTD SARS-COV-2 | FAST TRACK DIAGNOSTICS LUXEMBOURG S.A.R.L. | 315376 | 2023-09-22 | The manufacturer is no longer marketing the device. |
| PANBIO COVID-19 AG RAPID TEST DEVICE | ABBOTT RAPID DIAGNOSTICS JENA GMBH | 320577 | 2023-10-05 | The manufacturer is no longer marketing the device. |
| LIAISON SARS-COV-2 TRIMERIC IGG (CONTROL SET & DILUENT ACCESSORY) | DIASORIN INC. | 329600 | 2023-10-06 | The manufacturer is no longer marketing the device. |
| BINAXNOW COVID-19 ANTIGEN SELF TEST | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 341758 | 2023-10-11 | The manufacturer is no longer marketing the device. |
| ATELLICA IM SARS-COV-2 TOTAL (COV2T) | SIEMENS HEALTHCARE DIAGNOSTICS INC. | 316693 | 2023-08-29 | The manufacturer is no longer marketing the device. |
| ADVIA CENTAUR SARS-COV-2 TOTAL (COV2T) | SIEMENS HEALTHCARE DIAGNOSTICS INC. | 316549 | 2023-08-29 | The manufacturer is no longer marketing the device. |
| LUMIVI DIAGNOSTICS SARS COV-2 IGG RAPID TEST KIT | INTERNATIONAL POINT OF CARE, INC. | 324561 | 2023-09-05 | The manufacturer is no longer marketing the device. |
| NADAL COVID-19 IGG/IGM TEST | NAL VON MINDEN GMBH | 312778 | 2023-08-21 | The manufacturer is no longer marketing the device. |
| REAL-TIME FLUORESCENT RT-PCR KIT FOR DETECTING SARS-COV-2 | BGI EUROPE A/S | 312912 | 2023-08-22 | The manufacturer is no longer marketing the device. |
| SALIVA/SWAB RNA PURIFICATION 96-WELL KIT DX | NORGEN BIOTEK CORP. | 324746 | 2023-08-22 | The manufacturer is no longer marketing the device. |
| SALIVA RNA COLLECTION AND PRESERVATION DEVICES DX (50) | NORGEN BIOTEK CORP. | 324748 | 2023-08-22 | The manufacturer is no longer marketing the device. |
| SALIVA/SWAB RNA PURIFICATION KIT DX | NORGEN BIOTEK CORP. | 324750 | 2023-08-22 | The manufacturer is no longer marketing the device. |
| TOTAL NUCLEIC ACID PRESERVATION TUBES DX (50) | NORGEN BIOTEK CORP. | 324752 | 2023-08-22 | The manufacturer is no longer marketing the device. |
| TOTAL RNA PURIFICATION 96-WELL KIT DX (DEEP WELL FORMAT) (DX24350) | NORGEN BIOTEK CORP. | 327726 | 2023-08-22 | The manufacturer is no longer marketing the device. |
| TOTAL RNA PURIFICATION 96-WELL KIT DX (DEEP WELL FORMAT) (DX24380) | NORGEN BIOTEK CORP. | 327728 | 2023-08-22 | The manufacturer is no longer marketing the device. |
| EZ COLLECT SALIVA RNA DEVICE DX | NORGEN BIOTEK CORP. | 335889 | 2023-08-22 | The manufacturer is no longer marketing the device. |
| LIFE CONTROL REST DISPOSABLE MECHANICAL VENTILATOR (RESUSCITATOR) WITH RESTPORT | TMT TIBBI MEDIKAL MALZ. SAN. VE TIC. A. S. | 324920 | 2023-08-23 | The manufacturer is no longer marketing the device. |
| LYHER NOVEL CORONAVIRUS (COVID-19) ANTIGEN TEST KIT (COLLOIDAL GOLD) - NASAL | HANGZHOU LAIHE BIOTECH CO., LTD | 337385 | 2023-08-17 | The manufacturer is no longer marketing the device. |
| LIFERIVER NOVEL CORONAVIRUS (SARS-COV-2) REAL-TIME MULTIPLEX RT-PCR KI | SHANGHAI ZJ BIO-TECH CO., LTD | 313701 | 2023-08-18 | The manufacturer is no longer marketing the device. |
| ALTRIX PRECISION TEMPERATUE MANAGEMENT SYSTEM | STRYKER MEDICAL | 315283 | 2023-07-17 | The manufacturer is no longer marketing the device. |
| DIMENSION EXL SARS-COV-2 TOTAL ANTIBODY (CV2T) | SIEMENS HEALTHCARE DIAGNOSTICS INC. | 316783 | 2023-07-27 | The manufacturer is no longer marketing the device. |
| DIMENSION VISTA SARS-COV-2 TOTAL ANTIBODY (COV2T) | SIEMENS HEALTHCARE DIAGNOSTICS INC. | 316782 | 2023-07-27 | The manufacturer is no longer marketing the device. |
| ID NOW COVID-19 | ABBOTT DIAGNOSTICS SCARBOROUGH, INC. | 320087 | 2023-08-09 | The manufacturer is no longer marketing the device. |
| Care Start Covid-19 Antigen | Access Bio, Inc. | 327778 | 2023-07-14 | The manufacturer is no longer marketing the device. |
| Bi-spectrum Network Thermal Camera | Shenzhen Sunell Technology Corporation | 317948 | 2023-07-12 | The manufacturer is no longer marketing the device. |
| ABC Single Use Syringe / Sterile-eo/ Sterile/ Non-toxic / Non-pyrogenic | Revital Healthcare (EPZ) Ltd. | 328637 | 2023-07-12 | The manufacturer is no longer marketing the device. |
| Magnetiq Viral Rna Extraction Kit | Galenvs Sciences Inc. | 314136 | 2023-07-12 | The manufacturer is no longer marketing the device. |
| Face Shield (Non-medical) | Pujlang Shenfeng Packaging Material Co. Ltd | 317555 | 2023-07-12 | The manufacturer is no longer marketing the device. |
| Pleats Plus Particulate Respirator | Levitt-safety Ltd. Dba Northern Light Technologies | 325365 | 2023-07-13 | License issued |
| Precambrian Highflow Personal Respirator | Precambrian Products Inc. | 316087 | 2023-07-13 | The manufacturer is no longer marketing the device. |
| N95 Particulate Respirator | Guangzhou Harley Commodity Company Limited | 312933 | 2023-07-13 | License issued |
| Biovu Quattro | Televu Innovation Ltd. | 331730 | 2023-07-13 | The manufacturer is no longer marketing the device. |
| HCE101 Elsa System | Transonic Systems Inc. | 313625 | 2023-07-13 | The manufacturer is no longer marketing the device. |
| FZ Medical Ventilator | FZ Medical Inc. | 321488 | 2023-07-13 | The manufacturer is no longer marketing the device. |
| Lumiradx Sars-Cov-2 Ag Test | Lumiradx Uk Ltd | 332358 | 2023-06-26 | The manufacturer is no longer marketing the device in Canada |
| Bkit Virus Finder Covid-19 | Hyris S.R.L | 315999 | 2023-06-26 | The manufacturer is no longer marketing the device in Canada |
| Ellume Covid-19 Home Test | Ellume Limited | 333567 | 2023-06-26 | The manufacturer is no longer marketing the device in Canada |
| Peep-Alert Pressure And Flow Monitor | Peep-Alert Technologies, Inc. | 327293 | 2023-06-26 | The manufacturer is no longer marketing the device in Canada |
| Spartan Covid-19 System | Spartan Bioscience Inc. | 326379 | 2023-06-26 | The manufacturer is no longer marketing the device in Canada |
| Mgpure viral rna purification kit | Biomiga inc. | 324514 | 2023-06-05 | License issued |
| Elenium automation: healthgate desktop | elenium automation pty ltd. | 332509 | 2023-06-15 | The manufacturer is no longer marketing the device in Canada |
| Personal face shield | New paradigm graphics | 314877 | 2023-05-30 | The manufacturer is no longer marketing the device in Canada |
| Airqueen breeze mask | Hygiene protec inc. | 319665 | 2023-05-30 | The manufacturer is no longer marketing the device in Canada |
| Swab covid-19 | Canada inc. Operating as pama manufacturing & sterilization | 314006 | 2023-05-30 | License issued |
| Handheld thermal body temperature monitoring camera | Regpharm consulting inc. | 320239 | 2023-05-30 | The manufacturer is no longer marketing the device in Canada |
| Goodmanner premier defence mask KF94 | Handa HealthCare CO., LTD | 320592 | 2023-05-30 | License issued |
| Face mask | Dla piper (canada) llp | 320735 | 2023-05-30 | License issued |
| Loupe shield mark 1 | Yamaoka health technology inc. | 326230 | 2023-05-30 | License issued |
| Inventi mask | H3alth technologies inc. | 335029 | 2023-05-30 | License issued |
| Particle filtering half mask - ffp2 nr d | Dymon medical inc | 351564 | 2023-05-30 | License issued |
| Top dog manufacturing aami level 2 isolation gown | Top dog manufacturing | 315010 | 2023-06-02 | License issued |
| Covidx sars-cov-2 rapid antigen test | Lumos diagnostics incorporated | 330636 | 2023-05-26 | The manufacturer is no longer marketing the device in Canada |
| Procedural mask | Xiantao zhongtai protective products co., ltd. | 320207 | 2023-05-23 | License issued |
| Flat-fit healthcare respirator | Btl industries limited | 321112 | 2023-05-17 | The manufacturer is no longer marketing the device in Canada |
| Hynaut disposable medical mask | Qingdao hainuo biological engineering co. Ltd | 316593 | 2023-05-17 | License issued |
| Nitrile powder-free exam gloves | Medline industries, inc. Dba caring international | 319370 | 2023-05-19 | The manufacturer is no longer marketing the device in Canada |
| Medical Face Masks (Non-Sterile) | Xiantao Deming Healthcare Products Co. Ltd. | 313315 | 2023-05-12 | License issued |
| Onguard Protective Face Shield | Lumify Inc. | 313916 | 2023-05-12 | License issued |
| Face Shields | Heartland Agri-Vent Ltd | 314028 | 2023-05-12 | License issued |
| APT Face Shield | Answer Precision Tool Inc. | 314113 | 2023-05-12 | License issued |
| 7th Sense Nitrile Powder Free Examination Glove | Kossan International Sdn Bhd | 315186 | 2023-05-12 | The manufacturer is no longer marketing the device in Canada |
| Face Shield | 996838 Ontario Inc. O/A Miller McConnell Signs | 315601 | 2023-05-12 | License issued |
| Sterile Single-Use Swab Collection Device (SCD) | Primed Instruments Inc. | 316097 | 2023-05-12 | License issued |
| Shieldnl Personal Protective Equipment Face Shield / Écran Facial: Équipement de Protection Individuelle | Negan Group of Companies Incorporated | 316405 | 2023-05-12 | License issued |
| Hercules Oxygen Concentrator | ON2 Solutions | 316660 | 2023-05-12 | The manufacturer is no longer marketing the device in Canada |
| Eternity 95PFE Particulate Respirator | Eternity Medical Equipment Manufactural Inc. | 316669 | 2023-05-12 | License issued |
| Shieldnl Personal Protective Equipment Face Shield | Negan Group of Companies Incorporated | 317746 | 2023-05-12 | The manufacturer is no longer marketing the device in Canada |
| Omnigene Oral | DNA Genotek Inc. | 319758 | 2023-05-12 | License issued |
| Oracollect RNA | DNA Genotek Inc. | 322427 | 2023-05-12 | License issued |
| Medical Face Masks | Zhejiang Xichen Medical Technology | 326342 | 2023-05-12 | License issued |
| Emergency Relief Bed | Stryker Medical | 313706 | 2023-05-11 | The manufacturer is no longer marketing the device in Canada |
| Face Shield | Otis Technology | 314337 | 2023-05-11 | License issued |
| Aurora Anti-Fog Goggles | Shenzhen Aurora Technology Limited | 315281 | 2023-05-11 | The manufacturer is no longer marketing the device in Canada |
| Dr. Talbot's Non-Contact Infrared Thermometer | Talbots Pharmaceuticals Family Products Llc | 316556 | 2023-05-11 | The manufacturer is no longer marketing the device in Canada |
| Surgical Face Mask | Winner Medical Co., Ltd. | 328037 | 2023-05-12 | License issued |
| SOL-Guard 1ML TB Safety Syringe with fixed needle 25G X 1" | SOL-Millennium Medical, Inc | 328510 | 2023-04-18 | License issued |
| Medipines Gas Exchange Monitor | Medipines Corporation | 313459 | 2023-04-18 | License issued |
| Masque Epura Mask | Combomed Pharmaceutical Inc. | 313120 | 2021-09-08 | Risk outweigh benefits |
| AMSCO V-PRO Low Temperature Sterilization System | Steris Mexico | 313821 | 2021-10-22 | The manufacturer is no longer marketing the device in Canada |
| Confiderm 3.5c Nitrile Exam Gloves Powder-Free | Hartalega Ngc Sdn. Bhd. | 314296 | 2022-09-16 | License issued |
| Steriright Reprocessed Mask | Bay Area Health Trustee Corp. | 315025 | 2022-12-01 | The manufacturer is no longer marketing the device in Canada |
| Calneo Xair | Fujifilm Corporation | 315287 | 2022-12-15 | The manufacturer is no longer marketing the device in Canada |
| Dorma Respirators | M.I. Protection | 315359 | 2022-11-16 | The manufacturer is no longer marketing the device in Canada |
| Vaporous Hydrogen Peroxide Decontaminated Compatible N95 Respirators | Trent University | 315775 | 2022-11-23 | The manufacturer is no longer marketing the device in Canada |
| Amsco Century Medium Steam Sterilizer | Steris Mexico | 317027 | 2021-10-22 | The manufacturer is no longer marketing the device in Canada |
| Amsco 400 Series Medium Steam Sterilizer | Steris Mexico | 318685 | 2021-10-22 | The manufacturer is no longer marketing the device in Canada |
| RNA ISOLATION KIT | LUMINULTRA TECHNOLOGIES LTD | 313982 | 2023-04-03 | The manufacturer is no longer marketing the device in Canada |
| GENECOUNT COVID-19 RT-QPCR ASSAY KIT | LUMINULTRA TECHNOLOGIES LTD | 320936 | 2023-04-03 | The manufacturer is no longer marketing the device in Canada |
| Domrex Syringe Without Needle | Jiangsu Micsafe Medical Technology Co., Ltd | 327913 | 2023-03-23 | License issued |
| Domrex Syringe With Needle | Jiangsu Micsafe Medical Technology Co., Ltd | 327914 | 2023-03-23 | License issued |
| Domrex Hypodermic Needle | Jiangsu Micsafe Medical Technology Co., Ltd | 327915 | 2023-03-23 | License issued |
| Kinsa Quickcare | Kinsa, Inc. | 314227 | 2023-03-22 | License issued |
| Nipro Powder-Free Nitrile Examination Gloves | Nipro Corporation | 317244 | 2023-03-24 | The manufacturer is no longer marketing the device in Canada |
| Bd Veritor System For Rapid Detection Of Sars-Cov-2 | Becton Dickinson And Company (Bd) | 318420 | 2023-03-24 | The manufacturer is no longer marketing the device in Canada |
| Mvm Mechanical Ventilator | Vexos | 319627 | 2023-03-24 | The manufacturer is no longer marketing the device in Canada |
| Bd Kit For Rapid Detection Of Sar-Cov-2 | Becton Dickinson And Company (Bd) | 332680 | 2023-03-24 | The manufacturer is no longer marketing the device in Canada |
| Bd Flu + Syringe | Becton Dickinson S.A. | 343008 | 2023-03-24 | The manufacturer is no longer marketing the device in Canada |
| Clean Flow Healthcare Mini | Clean Works Medical | 313709 | 2023-03-23 | The manufacturer is no longer marketing the device in Canada |
| Vitros Immunodiagnostic Products Anti-Sars-Cov-2 Total Reagent Pack And Calibrator | Ortho-Clinical Diagnostics Inc. | 314476 | 2023-03-23 | The manufacturer is no longer marketing the device in Canada |
| Thermal Body Temperature Monitoring Camera | Dahua Technology Usa Inc. | 314830 | 2023-03-23 | The manufacturer is no longer marketing the device in Canada |
| Battelle Critical Care Decontamination System | Battelle Memorial Institute | 314986 | 2023-03-23 | The manufacturer is no longer marketing the device in Canada |
| Vitros Immunodiagnostic Products Anti-Sars-Cov-2 Igg - Reagent Pack, Calibrator And Control | Ortho-Clinical Diagnostics | 316661 | 2023-03-23 | The manufacturer is no longer marketing the device in Canada |
| Disposable Hemoperfusion Cartridge | Jafron Biomedical Co., Ltd. | 317573 | 2023-03-23 | The manufacturer is no longer marketing the device in Canada |
| Thermal Body Temperature Monitoring Station | Dahua Technology Usa Inc. | 317991 | 2023-03-23 | The manufacturer is no longer marketing the device in Canada |
| Vitros Immunodiagnostic Products Anti-Sars-Cov-2 Anti-Sars-Cov-2 Total Controls | Ortho-Clinical Diagnostics | 333617 | 2023-03-23 | The manufacturer is no longer marketing the device in Canada |
| Pulse Oximeter | Shenzhen Jumper Medical Equipment Co., Ltd | 316330 | 2023-03-22 | The manufacturer is no longer marketing the device in Canada |
| Facial Recognition Terminal | Hangzhou Hikvision Digital Technology Co., Ltd | 317627 | 2023-03-22 | The manufacturer is no longer marketing the device in Canada |
| Illumina Covidseq Test | Illumina, Inc. | 317679 | 2023-03-22 | The manufacturer is no longer marketing the device in Canada |
| Winnipeg Ventilator | Canadian Emergency Ventilators Inc. | 317756 | 2023-03-22 | The manufacturer is no longer marketing the device in Canada |
| Redx Floq Sars-Cov-2 Swab Negative Control | Microbix Biosystems Inc | 322390 | 2023-03-22 | The manufacturer is no longer marketing the device in Canada |
| Redx Floq Sars-Cov-2 Swab Positive Control | Microbix Biosystems Inc | 322391 | 2023-03-22 | The manufacturer is no longer marketing the device in Canada |
| Redx Sars-Cov-2 Negative Control | Microbix Biosystems Inc | 322392 | 2023-03-22 | The manufacturer is no longer marketing the device in Canada |
| Redx Sars-Cov-2 Positive Control | Microbix Biosystems Inc | 322393 | 2023-03-22 | The manufacturer is no longer marketing the device in Canada |
| Broncholab | Fluidda Nv | 327803 | 2023-03-22 | The manufacturer is no longer marketing the device in Canada |
| Berpu Safety Needle | Berpu Medical Technology Co., Ltd. | 330312 | 2023-03-22 | The manufacturer is no longer marketing the device in Canada |
| Oxygen Regulator L-1246 | Columbia Fire & Safety Ltd | 313644 | 2023-03-23 | The manufacturer is no longer marketing the device in Canada |
| Good Mask | Shan Ho Asia Pacific Limited | 317164 | 2023-03-23 | License issued |
| Digital Thermometer | Kangfu Medical Equipment Factory | 317061 | 2023-03-22 | License issued |
| Yocon Virus Sampling Kit | Yocon Biology Technology Company | 317541 | 2023-03-22 | License issued |
| Clearmask Transparent Face Mask | Clearmask, Llc | 315227 | 2023-03-24 | The manufacturer is no longer marketing the device in Canada |
| Veritas Face Shield Medical | Veritas Tools Inc. | 316022 | 2023-03-24 | The manufacturer is no longer marketing the device in Canada |
| Face Mask | Well Lead Medical Co., Ltd. | 313191 | 2023-03-23 | The manufacturer is no longer marketing the device in Canada |
| Surgical Face Mask | Well Lead Medical Co., Ltd. | 313193 | 2023-03-23 | The manufacturer is no longer marketing the device in Canada |
| Nasopharyngeal Airway | Well Lead Medical Co., Ltd. | 313346 | 2023-03-23 | The manufacturer is no longer marketing the device in Canada |
| Cae Reprocessed N95 Respirators | Cae | 314987 | 2023-03-23 | The manufacturer is no longer marketing the device in Canada |
| Lng Studios Face Shield | Lng Studios | 317750 | 2023-03-23 | The manufacturer is no longer marketing the device in Canada |
| Hc Class Face Shield | Solution Associates Inc. | 315484 | 2023-03-22 | The manufacturer is no longer marketing the device in Canada |
| Faceshield | Terra Reproductions Inc. | 315534 | 2023-03-22 | The manufacturer is no longer marketing the device in Canada |
| Rf1 Class Face Shield | Solution Associates Inc. | 316637 | 2023-03-22 | The manufacturer is no longer marketing the device in Canada |
| Dt Class Face Shield | Solution Associates Inc. | 318187 | 2023-03-22 | The manufacturer is no longer marketing the device in Canada |
| 3d Face Mask | Innolifecare | 334602 | 2023-03-22 | The manufacturer is no longer marketing the device in Canada |
| Surgical 3d Mask | Innolifecare | 335684 | 2023-03-22 | The manufacturer is no longer marketing the device in Canada |
| Kn95 Efficient Filtering Mask | Guangzhou Harley Commodity Company Limited | 315817 | 2023-03-22 | License issued |
| 95pfe-L3 Particulate Respirator | Layfield Canada Ltd. | 324962 | 2023-03-22 | License issued |
| Can95 Particulate Respirator | Vitacore Industries Inc. | 319398 | 2023-03-23 | License issued |
| Can99 Particulate Respirator | Vitacore Industries Inc. | 326642 | 2023-03-23 | License issued |
| Total Rna Purification Kit Dx | Norgen Biotek Corp. | 314587 | 2023-03-23 | License issued |
| Total Rna Purification 96-Well Kit Dx | Norgen Biotek Corp. | 321299 | 2023-03-23 | License issued |
| Injection Molded Np Swab | Southmedic Inc. | 317969 | 2023-03-22 | License issued |
| Triplelock SARS-CoV-2 Tests | Sqi Diagnostics Systems Inc. (Canada) | 313602 | 2023-02-20 | The manufacturer is no longer marketing the device. |
| Argene SARS-CoV-2 R-gene | Biomerieux Sa (France) | 314217 | 2023-02-16 | The manufacturer is no longer marketing the device. |
| Artofix Facepiece Filtering Respirator | Armfoam Inc. | 315509 | 2023-02-03 | The manufacturer is no longer manufacturing the device. |
| Insti COVID-19 Antibody Test | Biolytical Laboratories Inc. (Canada) | 326459 | 2023-02-01 | The manufacturer is no longer marketing the device. |
| Perkinelmer New Coronavirus Nucleic Acid Detection Kit | Perkinelmer, Inc. (United States) | 313232 | 2023-01-19 | The manufacturer is no longer marketing the device. |
| I-MED Gloves / I-MED Gants | I-MED Pharma Inc. | 314496 | 2023-01-16 | The manufacturer is no longer marketing the device. |
| Sky Screen Fish Shape KN95 Mask | Guangdong Golden Leaves Technology Development CO., LTD | 313491 | 2022-12-12 | The manufacturer is no longer marketing the device. |
| Bd Veritor At-home COVID-19 Test | Becton Dickinson And Company (Bd) (United States) | 334278 | 2022-10-26 | The manufacturer is no longer marketing the device. |
| One Health Medical Technologies Emergency Use Ventilator | One Health Medical Technologies INC. | 316070 | 2022-06-16 | The manufacturer is no longer marketing the device. |
| Protective Face Shield | Steer Medical Inc. | 314254 | 2022-05-31 | The manufacturer is no longer marketing the device |
| Commercial N95 Respirator | InnoLifeCare | 327717 | 2022-05-27 | The manufacturer is no longer marketing the device |
| Procedure Earloop Face Masks | Zik Global Inc O/A Canadian Health Masks | 320588 | 2022-05-06 | The manufacturer is no longer marketing the device |
| Surgical N95 Respirator | InnoLifeCare | 327716 | 2022-05-06 | Marketing has ceased |
| Bip Endotracheal Tube Evac | Bactiguard AB | 316728 | 2021-11-04 | Licence Issued |
| Bip Endotracheal Tube | Bactiguard AB | 316729 | 2021-11-04 | Licence Issued |
| Bip Foley Tempsensor | Bactiguard AB | 320967 | 2021-11-04 | Licence Issued |
| Kn95 medical protective masks | Shanghai Xiangsheng Trade Co., Ltd | 312838 | 2021-10-29 | Risks outweigh benefits |
| KN 95 Protective Mask | New Zhong Yang Technology (Shenzhen) Co. | 314410 | 2021-10-29 | Risks outweigh benefits |
| Medical Surgical Mask | Hehan Yadu Industrial Co., Ltd | 312807 | 2021-09-14 | The risks outweigh the benefits |
| 3 Ply Face Mask with Flat Earloop | Wuhan Morntrip Trading Co., Ttd | 312809 | 2021-09-14 | The risks outweigh the benefits |
| Mask | Xinxiang City Hongda Medical Material Limited Company | 312811 | 2021-09-14 | The risks outweigh the benefits |
| Daily Protective Face Mask | Mingshi Technology Co. LTD | 313113 | 2021-09-14 | The risks outweigh the benefits |
| Disposable Face Mask | Violet Home Textile Technology Co., Ltd | 313486 | 2021-09-14 | The risks outweigh the benefits |
| Face Mask | Guangdong Owgels Science & Technology Co., Ltd | 313487 | 2021-09-14 | The risks outweigh the benefits |
| N95 Particulate Respirator | Shanghai Dasheng Health Products Manufacture Co., LTD. | 321706 | 2021-08-26 | A foreign regulatory authority cancelled its authorization. |
| Synguard nitrile exam gloves | This cancellation only affects devices imported by Riell Inc that are labelled to be manufactured by Shandong INTCO Medical Products co., Ltd. (China) | 314820 | 2021-08-06 | The manufacturer is no longer marketing the device. |
| MEDICAL VINYL EXAMINATION GLOVES | ZIBO INTCO MEDICAL PRODUCTS CO., LTD. | 313104 | 2021-07-28 | The manufacturer is no longer marketing the device. |
| ATB Disposable Face Mask | Zhongshan ATB Medical Technology Company Limited | 314835 | 2021-07-06 | The manufacturer is no longer marketing the device in Canada |
| Spartan Cube Covid-19 System | Spartan Bioscience Inc. (Canada) | 313012 | 2021-01-22 | Terms and Conditions Were Not Met |
| Ventilator Battery | Interstate All Battery | 314497 | 2020-10-16 | Licence Issued |
| Kn95 Non-powered Air Purifying Particle Respirator | Senke Pharmaceutical (Chengdu) Co., Ltd | 313083 | 2020-05-08 | Risks Outweigh Benefits |
| Dtc3x N95 Particulate Respirator | Shanghai Dasheng Health Products Manufacture Co., Ltd. | 314322 | 2020-06-17 | Risks Outweigh Benefits |
| Respirator Disposable Face Mask (Kn95) | Groupe Ricochet Inc. | 312817 | 2020-06-23 | Risks Outweigh Benefits |
| Mapleswab Swabs | Shapetry Labs Inc. | 314196 | 2020-06-30 | Risks Outweigh Benefits |
| Protective Respirator (N95 Masks) | Hunan Triplex Precision Medical Devices Co. Ltd | 313261 | 2020-08-20 | Risks Outweigh Benefits |
| Nitrile Power Free Examination Gloves | This Cancellation Only Affects Devices Imported by Shanghai Lansheng Light Industrial Products Imp. & Exp. Corp., Ltd That Are Labelled to Be Manufactured by Hartalega Sdn. Bhd. (Malaysia) | 313909 | 2021-05-18 | Risks Outweigh Benefits |
| Technologist Choice Nitrile Medical Examination Gloves | Bio Nuclear Diagnostics Inc. | 314317 | 2021-06-02 | The manufacturer is no longer marketing the device. |
| Face Mask | Wuhan Aimmax Trade Co, Ltd. | 312810 | 2021-06-02 | The manufacturer is no longer marketing the device. |
| Singclean Disposable Medical Mask | Hangzhou Singclean Medical Products, Ltd. | 313477 | 2021-06-03 | The manufacturer is no longer marketing the device. |
| Granville Swab Nasopharyngeal Specimen Collection Device | Granville Biomedical Inc. | 319269 | 2021-09-20 | Terms and conditions not met |
| Biofire COVID-19 Test | Biofire Defense (United States) | 314097 | 2022-04-26 | The manufacturer is no longer marketing the device. |
| MEDICAL FULL FACE SHIELD (MODEL L600) | VIVA HEALTHCARE CANADA LTD. | 312808 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NETWORK THERMAL CAMERA, HANDHELD THERMOGRAPHY CAMERA | HANGZHOU HIKVISION DIGITAL TECHNOLOGY CO., LTD | 312820 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PERSONAL PROTECTIVE EQUIPMENT | HENAN TUOREN MEDICAL DEVICE CO., LTD. | 312915 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| BLUE SAIL DISPOSABLE PROTECTIVE FACE MASK | ZIBO BLUE SAIL INNOVATION CO., LTD | 313075 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| 3PLY DISPOSABLE MEDICAL MASK | JIANGSU SONACARE MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | 313081 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE PROTECTIVE CLOTHING | YANBIAN PACIFIC TEXTILE CO. LTD | 313111 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDICAL FACE MASK | HENAN YADU INDUSTRIAL CO. LTD | 313112 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE MASK NON WOVEN | V&Q MANUFACTURING CORPORATION LTD | 313114 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDICAL FACE MASKS | ANJI SPENQ INDUSTRIAL CO. LTD | 313119 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SURGICAL MASK | XIAN TAO XINGRONG PROTECTIVE PRODUCTS CO., LTD | 313126 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL FACE MASK & MEDICAL FACE SHIELD | SHANGHAI JINGJIU MEDICAL EQUIPMENT CO., LTD. | 313187 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELDS | FORD MOTOR COMPANY OF CANADA, LTD. | 313196 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL MASKS | XIAMEN EAGLEDON PHARMACEUTICAL CO., LTD. | 313244 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| BAUER FACE SHIELD | BAUER HOCKEY LTD. | 313287 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PROMED GEARS PROCEDURE FACE MASK | XIANTAO ZHIBO NON-WOVEN PRODUCTS CO.,LTD | 313288 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL MASK | LUOYANG KELIJIAN TECHNOLOGY CO., LTD. | 313397 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL MASK | TIANJIN SELEN SCIENCE & TECHNOLOGY | 313442 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| WANJIE MEDICAL FACE SHIELD | SHENZHEN BEIJING WANJIE MEDICAL DEVICE CORPORATION LIMITED | 313445 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MABELSHIELD | MABEL'S LABELS | 313474 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| WOODBRIDGE INOAC MASK | WOODBRIDGE INOAC TECHNICAL PRODUCTS | 313494 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PROCEDURE EARLOOP FACE MASKS | WUHAN DYMEX HEALTHCARE CO., LTD. | 313500 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| EMERGENCY PROTECTIVE CLOTHING FOR MEDICAL (NON STERILED) | JIANG SU BEAUME OUTDOOR PRODUCTS CO. LTD | 313507 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE PROTECTIVE CLOTHING | NANJING TRUST GARMENT COMPANY LTD. | 313509 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| VISIERE DE PROTECTION [PROTECTIVE FACE SHIELD] | HERO CREATIONS S.E.N.C. | 313516 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SURGICAL MASK (NOT STERILE) | QINGZHOU YAOWANG PHARMACEUTICAL CO., LTD | 313529 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| WURTH FACE MASK | SAFE WAY INDUSTRY (WUHAN) CO. LTD | 313547 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| KN95 FACE MASK | ANHUI B2 BIOTECHNOLOGY CO., LTD. | 313568 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE SURGICAL MASK | XIAMEN PROBTAIN NONWOVEN INC | 313569 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SHIELDZ: THE GREAT CANADIAN PROTECTIVE FACE SHIELD | LUMAWIZ INC. | 313594 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL MASK, DISPOSABLE MEDICAL PROTECTIVE CLOTHING, ISOLATION GOWN | TIANJIN SAIYUAN TECHNOLOGY CO., LTD | 313675 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| CAFORU MEDICAL FACE MASKS | GUANGDONG LEIQI COSMETICS CO,, LTD. | 313759 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FFP2 MEDICAL PROTECTIVE MASK | LIAONING SHENGJINGTANG BIOTECHNOLOGY CO.,LTD. | 313768 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ÉCRAN FACIAL | ASCENSIONX | 313769 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE SURGICAL MASKS | HENAN ZHONGJIAN MEDICAL EQUIPMENT SUPPLY LTD | 313770 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE MASK 3-PLY WITH EARLOOP/TIE | SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD. | 313772 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL FACE SHIELD | CHENGDU NEW AOGUAN MEDICAL INSTRUMENT CO., LTD. | 313773 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| AFS19 | AMHIL ENTERPRISES | 313892 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MDK - SINGLE-USE PROTECTIVE CLOTHING | MDK (SHANGHAI) MEDICAL PACKING CO., LTD | 313910 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL MASK | GUIZHOU JUNJIANG INDUSTRY CO., LTD | 313911 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE MASK DISPOSABLE | WUHAN TOPMED TRADING CO.,LTD | 313914 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| 3D FOLDABLE SURGICAL FACE MASK | SYNERTECH INT'L LTD. | 313915 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MUSKOKA SHIELD | SMART SAFE SCIENCE INC. DBA 3S SOLUTIONS | 313921 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| COMB-O SHIELD GC/VISIERE COMB-O GC | ELAB EXTRUSION INC. | 313938 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| B702 FFP2 NR | BEI BEI SAFETY CO., LTD. | 313961 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL PROTECTIVE GOWN | ANHUI MONIQUE MEDICAL MATERIALS CO. LTD | 314005 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| TINKERINE FACE SHIELD | TINKERINE 3D PRINT SYSTEMS | 314010 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FLS FACE SHIELD | FAST LINE STRIPING SYSTEMS LTD. | 314011 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PRUSA FACE SHIELD | CANADIAN NUCLEAR LABORATORIES (CNL) | 314013 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELDS | ADVANTAGE ENGINEERING INC. | 314015 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELDS | STRATAGEN 3D INC | 314016 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELDS | CAD MICROSOLUTIONS INC. | 314017 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE PROTECTIVE FACE SHIELD | PUBCO PRODUCTS INTERNATIONAL INC. | 314019 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELDS | EXO-S INC. | 314020 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELDS | DESIGNFUSION | 314021 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELDS | LEO LAB | 314022 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELDS | TALARIA | 314024 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELDS | EXERGY SOLUTIONS INC. | 314025 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELD | 1508235 ONTARIO INC DBA MICROFORUM | 314027 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELD WITH ELASTIC HEADBAND | SPS | 314029 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SINIX PPE FULL FACE SPLASH SHIELD | SINIX PPE | 314031 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PROTECTIVE FACE SHIELD | SIMPSON SCREEN PRINT & LITHOGRAPHY LTD. | 314033 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SHIELDPRO FACE SHIELD | SKANDACOR PRINT FINISHING | 314034 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| HD FACE SHIELD | INDUSTRIALISATION QUEBEC | 314035 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELD | INVAKOR TECHNOLOGIES | 314038 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PRODESIGN FACE SHIELD / PRODESIGN PROTECTOR GOWN | PRODESIGN SOLUTIONS | 314044 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| VISIERE DE PROTECTION-PROTECTIVE FACE SHIELDS | 9035-1255 QUEBEC INC (DBA APF MARKETING AND PLASTISEAL) | 314046 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PROTECTEUR FACIALE REUTILISABLE/REUSABLE FACE SHIELD | INNOVSCAN INC. | 314049 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| VISIERE MEDICALE | GROUP MD | 314050 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE PROTECTIVE CLOTHING FOR MEDICAL USE | NINGJIN RUNBODA MEDICAL PROTECTIVE PRODUCTS CO. LTD | 314057 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDICAL FACE SHIELD | ENTREPRISE ARTÉFACT URBAIN | 314083 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELDS | CCL | 314099 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MP FACE SHIELD | MP REPRODUCTIONS INC. | 314198 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FIDO MASK | FIDO MASK CO. LTD. | 314208 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PRUSA PROTECTIVE FACE SHIELD FSF | FOOTHILLS GROUP | 314270 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| 1. STERILE DISPOSABLE PROTECTIVE GOWN FOR MEDICAL USE 2. DISPOSABLE PROTECTIVE GOWN FOR MEDICAL USE | WEIHAI TEXTILE GROUP IMPORT & EXPORT CO., LTD. | 314321 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDICAL GOGGLE | SHENZHEN XUNYANG PRINTING&PACKAGING CO., LTD. | 314325 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE SURGICAL GOWN | HENAN JOINKONA MEDICAL PRODUCTS STOCK CO,. LTD | 314329 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDICAL FACE SHIELD | SHENZHEN XUNYANG PRINTING&PACKAGING CO., LTD. | 314331 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDICAL ISOLATION FACE SHIELD | HANGZHOU MEIQING DIGITAL TECHNOLOGY CO.. LTD | 314622 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDFACE-ST, MAGFACE-73, MAGFACE-88, MAGFACE-103, HELFACE-NH, MEDFACE-XTL, MEDFACE-XL | LEMCOTECH | 314641 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDFACE-XL-3410PE / MEDFACE-XTL-3410PE / MEDFACE-XTL-3410PO / MEDFACE-XL-3410PO | LEMCOTECH | 314645 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDPURE SURGICAL MASK | PUREPURGE INC. | 314700 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE MASK | GUANGDONG TAIBAO MEDICAL SCIENCE AND TECHNOLOGY CO., LTD | 314717 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE PROTECTIVE CLOTHING AGAINST INFECTIVE AGENTS | BEIJING WINSUNNY HARMONY SCIENCE & TECHNOLOGY CO., LTD. | 314759 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDICAL GOWN LEVEL 1 | SUPREME QUILTING (1970) LTD. | 314784 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| RECOVER FIELD BED | RANGER DESIGN | 314787 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MCSHIELD | MCWOOD STUDIOS INC. | 314831 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ANATOMIZ3D FACE SHIELD | ANATOMIZ3D MEDTECH PRIVATE LIMITED | 314833 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SHENGJIE MEDICAL SURGICAL MASK, SHENGJIE MEDICAL PROTECTIVE MASK, SHENGJIE KN95 PARTICULATE RESPIRATOR | WEIHAI SHENGJIE MEDICAL TECHNOLOGY CO. LTD | 314855 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELD | CANADIAN ADDITIVE MANUFACTURING SOLUTIONS | 314885 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDICAL FACE SHIELD | QMINE GEO-SERVICE CORP. | 314972 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDICAL SAFETY GOGGLES | GUANGZHOU JULONG SPORTS PRODUCTS CO. LTD. | 314978 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELD | THERMEX ENGINEERED SYSTEMS INC. | 314981 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| BLUESTAR DISPOSABLE FACE SHIELD | BLUESTAR PRODUCTS INC. | 315009 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| WEEPRO DISPOSABLE FACE SHIELD | WEETECT MATERIAL LIMITED | 315051 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| COVID-19 FACESHIELD | ORTHOPAEDIC SURGERY @ THE OTTAWA HOSPITAL | 315052 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| B&I FACE SHIELD | B&I TRIM PRODUCTS INC. | 315110 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE SURGICAL MASK | ZHEJIANG QUZHOU RONGBO MEDICAL INSTRUMENT CO., LTD. | 315116 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| HERO SHIELD | ELSON PRECISION MANUFACTURING INC. | 315121 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| GOWNS | SEA VALLEY TRADING | 315198 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PROTECTEUR FACIAL VISAGE ENTIER / FACE SHIELD FULL FACE | SANDMATE LES ATTACHES KARINA | 315207 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| RBR FACE SHIELD | REAUME BROS RACING | 315212 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELDS | FOOTLETIC INC. | 315238 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| GENERAL USE FACE SHIELDS | DF BARNES | 315378 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MCCARTHY, HUTTON AND BENNET GOWNS | DF BARNES | 315434 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELDS | IEFFICIENT CANADA INC | 315457 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| IN-SHIELD | INDSALE LTD./COMPLIPAK INC | 315483 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| VISIERE PROTECTRICE | GROUPE DPI | 315529 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FRONTLINE SHIELD/PROTECTEUR | IPEX | 315535 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| 10" LONG PET FACE SHIELD | IMPACT MACHINE DESIGN INC | 315540 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELD | ZHEJIANG LONGMED MEDICAL TECHNOLOGY CO., LTD | 315567 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL MASK | BAINING MEDICAL PRODUCTS CO., LTD | 315580 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ICON PROTECTIVE FACE SHIELD | ICON TECHNOLOGIES LIMITED | 315624 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SHAWN-LIM-VISOR-V17 | MAKELAB INC | 315647 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELD | MILLENNIUM STAR INC | 315649 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE OFF (FACE SHIELD) | MARLIN INDUSTRIAL PRODUCTS INC. | 315650 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| CLASS 1 EYE/FACE SHIELD | LOGIMATION TECHNOLOGIES INC. | 315651 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MW FACE SHIELD 2000 | MELLOW WALK FOOTWEAR INC. | 315659 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELD | UB SIGNS | 315665 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| CSHIELD | CRYOS TECHNOLOGIES INC. | 315675 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PLASTAIR SHIELD [VISIERE DE PROTECTION] | LUBECKI TECHNICAL HOLDINGS, DIV PLASTAIR | 315714 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| CGA FACE SHIELD | CGA FACE SHIELDS | 315716 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PROTECTIVE MASK | SHANGHAI HUAXIANG WOOLEN DRESSING CO., LTD | 315732 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| RESPIRATORY MASKS | SYNERTECH INT'L LTD. | 315843 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| HUMANTECH MASK - HUMAN ZERO YELLOW DUST PREVENTION MASK | HUMANTECH CO., LTD. | 315937 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| HYU-AN-CHEONG PLUS YELLOW DUST PREVENTION MASK | DM DEVELOPMENT CO., LTD | 315938 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MTC FACE SHIELD | 1378045 ONTARIO INC. O/A MTC | 315953 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| LOOP RAPID SCREENING BOOTH | ONETWOSIX DESIGN INC. | 316009 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DTM-4.0 FACE SHIELD | ALFRED SAUNDERS 3D DESIGN AND PRINTING SERVICES | 316021 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| VISIÈRE (FACESHIELD) | LES CREATIONS ELITE INC. | 316035 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| LEVEL 4 HIGH RISK ISOLATION GOWN WITH TAPE / LEVEL 3 HIGH RISK ISOLATION GOWN | MEDTECS INTERNATIONAL CORPORATION LIMITED | 316071 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DIYFACESHIELD | 9985077 CANADA INC | 316078 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SURGICAL FACE MASK | GRUPO 10X, SA DE CV | 316150 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE STERILIZED PROBE COVERS FOR ORAL, RECTAL AND UNDER ARM DIGITAL THERMOMETERS | PRO-HEALTH PLASTICS TECHNOLOGY CORPORATION | 316242 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NASOPHARYNGEAL SWAB | CANADIAN HOSPITAL SPECIALTIES LTD. DOING BUSINESS AS CHS | 316327 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SINGLE USE MEDICAL FACE MASK | HUNAN JIANYUAN MEDICAL SCIENCE AND TECHNOLOGY CO., LTD. | 316365 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| TWEC FFP2 MASK | FORMOSA ENERGY-CARBON COMPANY LTD. | 316394 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DJM ISOLATION EYES COVER | SHENZHEN DJ MEDICAL EQUIPMENT CO., LTD. | 316407 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELD | SHENZHEN DJ MEDICAL EQUIPMENT CO., LTD. | 316408 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDICAL SURGICAL FACE MASK | TAIZHOU RICH MEDICAL PRODUCTS CO., LTD. | 316470 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| 3K FACE SHIELD | 3K TELEKOM TIC. LTD. STI. | 316493 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELD | SHENZHEN YIHUIJIA PRINTING MATERIAL CO. LTD | 316511 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDICAL FACE MASK (NOT STERILE) | HUNAN DIMS BIOTECHNOLOGY CO., LTD | 316560 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELD | SHENZHEN KEYMY PACKAGE LIMITED | 316608 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELD | WHENZOU ZHUANGXIN PACKING CO. LTD. | 316656 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL FACE MASK | HUAIYIN MEDICAL INSTRUMENTS CO., LTD. | 316698 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| VISIERES | PRESENTATION ULTIMA INC. | 316750 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PPEB: PERSONAL PROTECTIVE ENDOSCOPIC BOX | AGILE MV INC. | 316773 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| 3DQUE EAR SAVERS | 3DQUE MEDICAL INC. | 316786 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| 3DQUE FACE SHIELD | 3DQUE MEDICAL INC. | 316787 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| AD DISPLAY FACE SHIELD | AD DISPLAY (133876 CANADA INC.) | 316806 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| HC SAFETY FACE SHIELD | HO CHENG SAFETY ENTERPRISE CO., LTD | 316816 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ÉCRAN DE PROTECTION FACIAL | CÉGEP DE RIVIÈRE-DU-LOUP | 316831 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDICAL SURGICAL MASK | HENAN HUIBO MEDICAL CO., LTD | 316880 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MASKS | HUNAN TRIPLEX PRECISION MEDICAL DEVICES CO. LTD | 317036 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE ISOLATION GOWN | HEFEI C&P NONWOVEN PRODUCTS CO.,LTD | 317053 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL FACE MASK / PARTICULATE RESPIRATOR | ZHENGZHOU WANSHENSHAN HEALTHCARE PPE CO., LTD. | 317073 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELDS | CONFEDERATION COLLEGE | 317203 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| RESPIRATORY PROTECTION MASK KN95 | DK MEDICAL GMBH | 317309 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| RESPIRATORY PROTECTION MASK | DK MEDICAL GMBH | 317314 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| VTM-C19 TRANSIT TUBE | BIOMED DIAGNOSTICS INC | 317455 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDICAL PROTECTIVE MASK (NON-STERILE) | HUNAN SANRUI BIOTECHNOLOGY CO., LTD. | 317727 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SURGICAL FACE MASK | MODERN HEALTHCARE CORP | 317989 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SINGLE-USE MEDICAL FACE MASK | CABBEEN CLOTHING (CHINA) CO.,LTD | 318029 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| HAVEPUR DISPOSABLE MEDICAL MASKS | SHENZHEN HUAYUAN HAVEPUR MEDICAL TECHNOLOGY CO., LTD. | 318200 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| TITAN XL FACE SHIELD, TITAN SM FACE SHIELD | TITAN INNOVATIVE DESIGNS INC. | 318266 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| TWO PIECE FACE SHIELD 1.0 | INKBOX INK INC. | 318267 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| HEALTH PRO SURGICAL MASK | HEALTH PRO SUPPLIES LIMITED | 318340 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| S1000/S1000R FACE SHIELD | PYRAMEX SAFETY PRODUCTS | 318342 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| CNDAJI KN95 PROTECTIVE FACE MASK | GUANGZHOU DAJI MEDICAL SCIENCE AND TECHNOLGY CO., LTD. | 318418 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SHIELD48 REUSABLE FACE SHIELD | 3D TECHNOLOGY SIA | 318492 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MONITIO ESSENTIAL - SELF ASSESSMENT SCREENING STATION | MONITIO INTELLIGENCE INC. | 318660 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| AEROCK SHIELD | AEROCK | 318666 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| CAP SHIELD | VITAL MANUFACTURING INC. (DBA CAP SHIELD) | 318828 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| KINGFA MASK | GUANGDONG KINGFA SCL & TECH CO. LTD | 318920 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE ARMOR - DISPOSABLE FACE MASK | PURVIC INTERNATIONAL HK LTD. | 319018 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE THERMOMETER | MEDICAL INDICATORS INC. | 319218 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| TRAXIT WEARABLE CHILDREN'S UNDERARM THERMOMETER | MEDICAL INDICATORS INC. | 319219 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PROMED GEARS SURGICAL FACE MASK | MODERN HEALTHCARE CORP | 319256 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| INTERMASK DISPOSABLE MEDICAL MASK (NON-STERILE) | HUZHOU WECAN NEW MATERIAL TECHNOLOGY CO. LTD | 319339 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| 2KR VISOR - S | THERMOPLASTICS LTD. | 319395 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DR. FAMILY DISPOSABLE NON-MEDICAL FACE MASK (KN95) | JINHUA JIADAIFU MEDICAL SUPPLIES CO. LTD | 319402 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SINGLE-USE MEDICAL FACE MASK | GUANGZHOU DOUBLE ONE LATEX PRODUCTS CO., LTD. | 319511 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ANOSMIC COVID-19 SMELL TESTER | VIROCULE INC. | 319520 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FOREST VILLAGE KF94 MASK | THE BIO | 319590 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| UNISEX FACE CROWN SHIELD | O.L.C. ESSENTIAL PRODUCTS | 319628 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELD | TRANSOM CORPORATION | 319650 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELD PLUS | FABRICA DE ARTICULOS PLASTICOS GUATEPLAST, S.A. | 319744 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SUMEASY MEDICAL PROCEDURE EARLOOP MASK (NON-STERILE) | SUMEASY ENTERPRISE CO LTD | 319832 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELD | TRANSOM CORPORATION | 319844 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| N95 DISPOSABLE RESPIRATOR | MAKRITE INDUSTRIES INC. | 319849 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| THERMACHECK | PLANCK VISION SYSTEMS | 320015 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NEOGUARD 3PLY MEDICAL FACE MASK WITH EARLOOP | NEOMEDIC LTD. | 320023 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FFP2 NR DISPOSABLE RESPIRATORY MASK | SYNERTECH INT'L LTD. | 320097 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL MASK | GUANGZHOU DARUI REPRODUCTIVE TECHNOLOGY CO., LTD. | 320218 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ILLUSTRA PRO THERMAL BLACK BODY BDL | ILLUSTRA, A DIVISION OF SENORMATIC ELECTRONICS LLC | 320285 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SLEEPY 1030XA-TAS PROTECTIVE COVERALL | KAE HWA INDUSTRIAL CO., LTD. | 320334 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| KHNC 1530 ISOLATION GOWN | KAE HWA INDUSTRIAL CO., LTD. | 320336 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL FACE MASK (NON-STERILE) | DONGGUAN TENSUM HEALTH & TECHNOLOGY CO., LTD. | 320667 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SAFE WEAR ISOLATION GOWN - DISPOSABLE | KOLONNA MANUFACTURING (PVT) LTD. | 320677 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ISOLATION GOWN/ BLOUSE D'ISOLATION | ROBOCUTS | 320714 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| AT-HOME COVID-19 TEST | P23 LABS, LLC | 320720 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| GALIA N95 PROFESSIONAL RESPIRATOR | GALIA TEXTIL S.A. DE C.V. | 320888 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| THE HUMANITY SHIELD | CLEAR ADVANTAGE PPE LTD | 320939 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL FACE MASK | JIANGSU JICHUN MEDICAL DEVICES CO LTD | 321057 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| CMASK 3-PLY MEDICAL MASK WITH EARLOOPS | PERFECT TEC (CANADA) LIMITED | 321209 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PROCEDURE FACE MASK | HUI ZHOU TIAN CHANG INDUSTRIAL CO., LTD. | 321220 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PRAIRIEZ DISPOSABLE ISOLATION GOWN | CHAWALA ENTERPRISES | 321259 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| JMA MEDICAL FACE MASKS | T LEAF TRADING LTD | 321304 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| 95PFE FLAT FOLD PARTICULATE RESPIRATOR | BREATHE MEDICAL MANUFACTURING | 321363 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| YAFOX MEDICAL SURGICAL FACE MASK TYPE IIR | ZAIDTEK ELECTRONIC TECHNOLOGY (XIAMEN) CO., LTD. | 321365 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PARTICLE FILTERING HALF MASK (FFP2 NR) | HUI ZHOU TIAN CHANG INDUSTRIAL CO., LTD. | 321384 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL FACE MASK | WILSON TECH (INTERNATIONAL) LIMITED | 321463 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| CLEAR VISION COMFORT FACE SHIELDS | PERGO MEDIKAL | 321484 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FRESH KF94 MASK | MITIO CO. LTD | 321562 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SANITEK PRO N95 RESPIRATOR | GRUPO 10X, SA DE CV | 321721 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MY ACCESS MASK | MCRAE IMAGING INC. | 321777 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| AAMI ISOLATION GOWN LEVEL 1, 2 & 3 | EKOMED TEKSTIL MEDIKAL A.S. | 321812 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SURGICAL FACE MASK | FOSHAN XINBAO TECHNOLOGY CO., LTD | 321885 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ECM SHIELD | ECM HEALTH INC. | 321907 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NUMBER ONE GUARD MASK (KF94) | HAPPY DAY INC. | 321944 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SURGICAL FACE MASK | SYNERTECH INT'L LTD. | 322282 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| VERI-Q PREP M16 NUCLEIC ACID EXTRACTION DEVICE | MICOBIOMED CO., LTD. | 322354 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE FACE MASKS | HAFFNER MAKINA SANAYI VE TICARET A.S. | 322369 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| IOT INNOVA FACE SHIELD | IOT INNOVA INC. | 322617 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| N95 PARTICULATE RESPIRATOR NON-SURGICAL MASK | RIZHAO SANQI MEDICAL & HEALTH ARTICLES CO. LTD | 322636 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NON-SURGICAL ISOLATION GOWN | BANGLADESH EXPORT IMPORT COMPANY (BEXIMCO) LIMITED | 322790 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FEVERFILTER | LITENS HEALTH INC. | 322870 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| COROWELL COVID-19 SYMPTOM SCREENING TEST | MKG CONSULTING UG | 322927 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| HEALTH PRO FFP2 RESPIRATOR | HEALTH PRO SUPPLIES LIMITED | 323002 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| 1MASKS DISPOSABLE RESPIRATOR | SPRO MEDICAL PRODUCTS (XIAMEN) CO. LTD. | 323056 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SKYCARE KF94 | SKYBIO CO., LTD. | 323060 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| KN95 RESPIRATORY PROTECTIVE MASK | SYNERTECH INT'L LTD. | 323146 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ISOLATION GOWNS | WUJIANG TUTAIKE TEXTILES & FINISHING CO., LTD. | 323179 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| 3PLY DISPOSABLE MEDICAL MASK | WELSPUN INDIA | 324409 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SKYPRO SP01 PROCEDURE MASK | SKYPRO MEDICAL SUPPLIES CO. | 324441 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| TYPE IIR MEDICAL FACE MASK | GUIZHOU RUIKANG MEDICAL PROTECTIVE EQUIPMENT CO., LTD | 324442 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SKYPRO JUNIOR SURGICAL MASK | SKYPRO MEDICAL SUPPLIES CO. | 324840 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SKYPRO CLASSIC SURGICAL MASK | SKYPRO MEDICAL SUPPLIES CO. | 324842 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| KOIBE STANDARD SIGNATURE WHITE HEALTH MASK (KF94) | ULINE KOREA CO., LTD. | 324944 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PREMIUM 4 PLY SURGICAL MASK AND PREMIUM 3 PLY SURGICAL MASK | KEEO LIFE PRIVATE LIMITED | 325435 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FLEXAIR HE PAPR SYSTEM | AIRBOSS DEFENSE GROUP | 325523 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| WYMASK | WYM GROUP INC. | 326455 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FLIGHT MASK BRACE | FUNKY MATTER INC. | 326798 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| KCE DISPOSABLE MEDICAL MASK | SHENZHEN KECAI PRINTING CO., LTD. | 327061 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDFIELD MEDICAL MASK | ZHEJIANG JASMINE ORALCARE PRODUCTS CO., LTD. | 327155 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SMARTVISOR+ | KINGSBURY PRESS LTD. | 327333 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE ISOLATION GOWN NON-STERILE LEVEL-2 | HEFEI C&P NONWOVEN PRODUCTS CO.,LTD | 327441 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE ISOLATION GOWN NON-STERILE LEVEL 1 | HEFEI C&P NONWOVEN PRODUCTS CO.,LTD | 327444 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| GENERAL MEDICAL FACE MASK | EASTING BIOTECHNOLOGY CO., LTD. | 327471 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| HS SURGICAL MASK ASTM LEVEL 3 DISPOSABLE 3 PLY SURGICAL MASK WITH EAR-LOOPS | RG NEGOCIOS DINAMICOS S DE RL DE CV | 328233 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| N95 FFP2 PROTECTIVE MASK | ROSEMERTA TECHNOLOGIES LIMITED | 328412 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| INNOVALIFE CLEAR MASK | INNOVATOOLS INC. | 328823 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SELF-CONTAINED NEGATIVE PRESSURE ENVIRONMENT | SCONE MEDICAL SOLUTIONS INC. | 328827 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ISOLATION GOWN AAMI LEVEL 2 | INTCO MEDICAL (HK) CO. LTD | 329069 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ISOLATION GOWN AAMI LEVEL 3 | INTCO MEDICAL (HK) CO. LTD | 329071 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SURGICAL FACE MASK | RIZHAO SANQI MEDICAL & HEALTH ARTICLES CO. LTD | 329257 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SURGICAL FACE MASK | RIZHAO SANQI MEDICAL & HEALTH ARTICLES CO. LTD | 329268 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE ISOLATION GOWN NON-STERILE, AAMI PB70 LEVEL 3 | HEFEI C&P NONWOVEN PRODUCTS CO.,LTD | 329747 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SLEEPY2730XA PROTECTIVE COVERALL | KAE HWA INDUSTRIAL CO., LTD. | 329967 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| COVID MASK | CLINKEEP CO., LTD. | 330732 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL MASKS (FOLDABLE) | ANHUI HEALTH BOX TECHNOLOGY CO., LTD. | 330763 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SURGICAL TYPE IIR MASKS | HEIQ MEDICA S.L. | 331457 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PROTECTIVE GOGGLES WITH SILICONE STRAP | HANGZHOU RETSING EYEWEAR CO.,LTD | 331522 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| COVERU DISPOSABLE GOWN WITH TAPE AAMI LEVEL 4 ISOLATION GOWN | MEDTECS(CAMBODIA) CORP. LIMITED | 332624 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DEMI MASQUES FILTRANTS-FFP2 NR D | MDB TEXINOV | 332732 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| 3DMASK ULTRA | SAVEWO INTERNATIONAL LIMITED | 332997 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SUTRA | SUTRIN INC. | 333413 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SUTRA (3029 PFE100 L3) | SUTRIN INC. | 333415 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FFP2 NR RESPIRATORY MASK WITH EARLOOPS | SYNERTECH INT'L LTD. | 334099 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SURGICAL RESPIRATOR N95 PFE-L2 | EKOMED FREE ZONE MEDIKAL TEKSTIL SAN. TIC. AS. | 335791 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SAVEWO 3DMASK EX PRO | SAVEWO INTERNATIONAL LIMITED | 336557 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| 3DBEAR DISPOSABLE MEDICAL MASK | SAVEWO INTERNATIONAL LIMITED | 341198 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| 3DMASK SMILE | SAVEWO INTERNATIONAL LIMITED | 341199 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PROTECTIVE EARLOOP FACE MASK | ZHUHAI IVI MEDICAL DEVICE CO. LTD. | 342562 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| WEAIR PROTECTIVE FACE MASK | QINGDAO HAINUO BIOLOGICAL ENGINEERING CO. LTD | 343521 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL FACE MASKS | XIANTAO DINGCHENG NON-WOVEN PRODUCTS CO.,LTD. | 351923 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDPRIDE SYNTHETIC VINYL EXAM GLOVES | SHIELD LINE LLC | 321878 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDPRIDE MEDICAL EXAMINATION VINYL GLOVES | SHIELD LINE LLC | 321880 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| EA323 ENTERAL FEEDING PUMP | LIFEPUM MEDITECH CO.,LTD | 313007 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NATURAMED POWDER FREE VINYL EXAMINATION GLOVES | NATURA LIFESTYLE INC. | 313073 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| STARMED CASTAR HOOD FOR NON INVASIVE VENTILATIONSJM TAILOR ANNULOPLASTY RING | INTERSURGICAL S.P.A. | 313107 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ALBERTA COVID CPAP HOOD | GEMMA PLASTICS | 313656 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| CERASHIELD ENDOTACHEAL TUBE | N8 MEDICAL, LLC | 313659 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| BIOQUELL SYSTEM | BIOQUELL UK LTD | 313881 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE NITRILE EXAMINATION GLOVES | ZHONGHONG PULIN | 314045 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NON-CONTACT INFRARED THERMOMETER | DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO. LTD. | 314047 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DIGITAL THERMOMETER | HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., LTD. | 314055 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SPIRIT HEALTHCARE GROUP JMBOO DIGITAL THERMOMETER | ARA PHARMACEUTICALS INC. | 314108 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| INFRARED FOREHEAD THERMOMETER | CONMO ELECTRONIC COMPANY LIMITED | 314126 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MCKESSON POWDER-FREE VINYL EXAM GLOVES | SHANDONG INTCO MEDICAL PRODUCTS CO., LTD. | 314138 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| CDR ACUTE DECONTAMINATION SYSTEM | CDR SYSTEMS INC. | 314256 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| BACTERIAL/VIRAL FILTER | VINCENT MEDICAL MANUFACTURING CO., LTD. | 314268 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| AIR NEXT SPIROMETER | NUVOAIR AB | 314633 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| AEROSOL-REDUCING MASK FOR USE WITH BIPAP AND CPAP MACHINES | GLIA INC. | 314674 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| RHINO HEALTH NITRILE GLOVE | RHINO HEALTH, INC. | 314725 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ACCUTACH PNEUMOTACH FLOW SENSOR | B&B MEDICAL TECHNOLOGIES | 314765 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NEXTEMP PLUS DISPOSABLE THERMOMETER WITH RECTAL SHEATH | MEDICAL INDICATORS INC. | 314807 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE NITRILE EXAMINATION GLOVES | ZHONGHONG PULIN MEDICAL PRODUCTS CO., LTD. | 314812 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NON-CONTACT INFRARED THERMOMETER | ALICN MEDICAL SHENZHEN, INC | 314819 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NON-CONTACT INFRARED BODY THERMOMETER | HETAIDA TECHNOLOGY CO., LTD | 314836 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| BOKANG INFRARED FOREHEAD THERMOMETER (NON-CONTACT) | WENZHOU BOKANG INSTRUMENTS CO. LTD. | 314883 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE THERMOMETER COVERS AND SHEATHS | KANG ZE INDUSTRIAL CO., LTD | 314926 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE THERMOMETER | MEDICAL INDICATORS INC. | 314985 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| BESANTEK NON-CONTACT FOREHEAD IR THERMOMETER | BESANTEK CORPORATION | 315077 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| INFRARED THERMOMETER | VISIOMED TECHNOLOGY CO., LTD. | 315219 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SURGICAL GLOVES | SHANGHAI MOTEX HEALTHCARE CO. LTD | 315542 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PEEP VALVE | REDFLUID | 315940 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PULSEHALER | RESPINOVA LTD | 316050 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| BREATHING TUBE | BMC MEDICAL CO., LTD. | 316058 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| IR236 | WUHAN GUIDE SENSMART TECH CO., LTD. | 316069 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FLIR | FLIR UNMANNED AERIAL SYSTEMS | 316151 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FOREHEAD THERMOMETER | AMERICAN THERMAL INSTRUMENTS INC. DBA ATI, INC. | 316206 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| INFRARED BODY THERMOMETER | HETAIDA TECHNOLOGY CO., LTD | 316216 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MISC LARYNGOSCOPES | MEDICAL DEVICES (PVT) LTD | 316217 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NON-CONTACT INFRARED BODY THERMOMETER | HETAIDA TECHNOLOGY CO., LTD | 316221 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| INFRARED FOREHEAD THERMOMETER | SHENZHEN MEDEK BIO-MEDICAL CO., LTD | 316233 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DIGITAL BARRIERS ELEVATED TEMPERATURE SCREENING SYSTEM | DIGITAL BARRIERS SERVICES LIMITED | 316491 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| INFRARED THERMOMETER | SHENZHEN PACOM MEDICAL INSTRUMENTS CO., LTD. | 316644 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| INFRARED FOREHEAD THERMOMETER | SHENZHEN LEPU INTELLIGENT MEDICAL EQUIPMENT CO., LTD | 316683 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| QLEANKITS | 3DQUE MEDICAL INC. | 316784 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NON-CONTACT FOREHEAD INFRARED THERMOMETER | SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD. | 316809 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PRONITRILE NITRILE EXAMINATION GLOVES POWDER FREE | PROFESSIONAL LATEX SDN. BHD. | 316856 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| VINYL MEDICAL GLOVES | GLOBE COMMERCIAL PRODUCTS | 317681 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| INFRARED FOREHEAD THERMOMETER | KNECTEK LABS INC. | 317731 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| INFRARED NON CONTACT BODY THERMOMETER | 2109971 ONTARIO INC. DBA KROSS DIRECT | 317997 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ICI NON-CONTACT INFRARED THERMOMETER | INFRARED CAMERAS INC. | 318038 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| GENIAL INFRARED FORHEAD THERMOMETER / GENIAL DIGITAL THERMOMETER | GUANGDONG GENIAL TECHNOLOGY CO., LIMITED | 318208 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| TNI SOFTFLOW 50 | TNI MEDICAL AG | 318220 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SIMZO NON-CONTACT FOREHEAD THERMOMETER | DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO. LTD. | 318510 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NVIMEDIC POWDER FREE NITRILE LATEX EXAMINATION GLOVES | NAM VIET GLOVE JOINT STOCK COMPANY | 318729 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| THERMOWORKS WAND, NON-CONTACT DIGITAL FOREHEAD THERMOMETER | THERMOWORKS | 318876 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| INFRARED THERMOMETER | FLTR, INC. | 319020 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| CONNECTOR | DEAS S.R.L. | 319187 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| BREATHING SYSTEM HEAT AND MOISTURE EXCHANGER FILTER | DEAS S.R.L. | 319190 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| BREATHING CIRCUIT | DEAS S.R.L. | 319209 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| CATHETER MOUNT | DEAS S.R.L. | 319216 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NON-CONTACT FOREHEAD THERMOMETER | FORGE PRODUCTS INC. | 319259 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| LOW-PRESSURE HOSE ASSEMBLY FOR USE WITH MEDICAL GASES | GENTEC (SHANGHAI) CORPORATION | 319564 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| AMMEX PROFESSIONAL - BLUE NITRILE EXAM GLOVES | AMMEX CORPORATION | 319593 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| INFRARED THERMOMETER | SHENZHEN CALIBEUR INDUSTRIES CO., LTD. | 319771 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| VGLOVE POWDER FREE NITRILE EXAMINATION GLOVES | VRG KHAI HOAN JOINT STOCK COMPANY | 319874 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE NITRILE EXAMINATION GLOVES | ZIBO BLUE SAIL INNOVATION CO., LTD | 319994 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDICAL INFRARED THERMOMETER | HUNAN HONGGAO ELECTRONIC TECHNOLOGY CO. LTD. | 319997 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NEOGLOVES NITRILE POWDER-FREE EXAMINATION GLOVES | NEOMEDIC LTD. | 320021 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| INFRARED THERMOMETER | SHANDONG BITTEL INTELLIGENT TECHNOLOGY CO., LTD. | 320040 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES | DIPPED PRODUCTS (THAILAND) LIMITED | 320114 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NITRILE EXAMINATION GLOVES | LYNCMED MEDICAL TECHNOLOGY (BEIJING)CO.,LTD | 320369 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ADVOCATE NON-CONTACT INFRARED THERMOMETER | BROADMASTER BIOTECH CORP. | 320604 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE VINYL GLOVES | LYNCMED MEDICAL TECHNOLOGY (BEIJING)CO.,LTD | 320818 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| LALUNE FOREHEAD THERMOMETER | LALUNE TRADING LTD. | 320820 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| GENERAL PURPOSE DISPOSABLE SYRINGES WITH NEEDLE | SHANDONG QIAOPAI GROUP CO. LTD. | 320873 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PULMONE MINIBOX+ | LUVO MEDICAL TECHNOLOGIES, INC. | 320928 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| UNISPACE HEALTH BLUE NITRILE LONG CUFF EXAMINATION GLOVES | UNISPACE HEALTH PRODUCTS LLP | 321168 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| TITANFINE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES | HEBEI TITANS HONGSEN MEDICAL TECHONOLOGY CO. LTD. | 321176 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NON-CONTACT INFRARED THERMOMETER | SHENZHEN BRAV ELECTRONIC TECHNOLOGIES CO., LTD. | 321449 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DIKANG MEDICAL INFRARED THERMOMETER | HUNAN HONGGAO ELECTRONIC TECHNOLOGY CO. LTD. | 321978 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PURETECH RESPIRATOR DISINFECTION DEVICE | MEDERA TECHNOLOGIES INC. | 322059 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDICAL INFRARED THERMOMETER | SHENZHEN PACOM MEDICAL INSTRUMENTS CO., LTD. | 322071 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| CORE-MEDIUM SYSTEM | INCORE CO., LTD | 322123 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PULSE OXIMETER | SHENZHEN IMDK MEDICAL TECHNOLOGY CO., LTD. | 322381 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| INFRARED THERMOMETER | GLOBE COMMERCIAL PRODUCTS | 322421 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE SYRINGES 1ML LUER LOCK | JIANGSU EYOUNG MEDICAL DEVICES CO. LTD. | 322708 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE NEEDLE | JIANGSU EYOUNG MEDICAL DEVICES CO. LTD. | 323072 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PROTECTOR RAY 10 | BRISSON SCIENCE CORP. | 324429 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| INFRARED FOREHEAD THERMOMETER | HANGZHOU UNIVERSAL ELECTRONIC CO. LTD | 324435 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| BABY TEMP DUOSMART THERMOMETER | DAGAMMA ECOMMERCE SOLUTIONS INC. | 324831 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| INFRARED THERMOMETER | SUZHOU MELODICARE MEDICAL TECHNOLOGY CO., LTD. | 324924 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DAGAMMA PULSE OXIMETER | DAGAMMA ECOMMERCE SOLUTIONS INC. | 325288 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE NEEDLES | JIANGSU EYOUNG MEDICAL DEVICES CO. LTD. | 326942 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE SYRINGES | JIANGSU EYOUNG MEDICAL DEVICES CO. LTD. | 326943 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PULSE OXIMETER | SHENZHEN AEON TECHNOLOGY CO., LTD. | 326964 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| BLUE NITRILE EXAM GLOVES | ASIA DYNAMICS INC. DBA ADI MEDICAL | 327012 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE SAMPLER INACTIVATED TRANSPORT MEDIA | WUXI NEST TECHNOLOGY CO., LTD. | 327528 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE SYRINGE AND SAFETY NEEDLES | YANGZHOU MEDLINE INDUSTRY CO., LTD. | 327873 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE SYRINGE DISPOSABLE SYRINGE WITH NEEDLE | ANHUI EASYWAY MEDICAL SUPPLIES CO., LTD | 327904 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE SYRINGE FOR SINGLE USE & AUTO-DISABLE SYRINGE | JIANGXI SANXI MEDTEC CO,. LTD. | 327910 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE SYRINGE AND HYPODERMIC NEEDLE | CHANGZHOU CHUANGJIA MEDICAL APPLIANCE CO., LTD. | 327937 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| STERILE HYPODERMIC SYRINGE | JIANGSU SHENLI MEDICAL PRODUCTION CO., LTD. | 328099 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MCKESSON NEEDLES | JIANGSU CAINA MEDICAL CO., LTD. | 328274 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOABLE SYRINGE WITH NEEDLE 1ML 25G X 1" | CHANGZHOU SHUANGMA MEDICAL DEVICE | 328290 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE SYRINGE 1ML | CHANGZHOU SHUANGMA MEDICAL DEVICE | 328292 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDBEC STERILE SYRINGE WITH NEEDLE, LUER SLIP, 1ML | ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD. | 328336 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| 1 ML DISPOSABLE SYRINGE LUER LOCK | ZHEJIANG HUAFU MEDICAL EQUIPMENT CO., LTD. | 328342 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDBEC STERILE SYRINGE WITHOUT NEEDLE, LUER SLIP, LOW DEAD SPACE, 1ML | ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD. | 328376 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| TKMD DISPOSABLE SYRINGE WITHOUT NEEDLE 1CC/ML | ANHUI TIANKANG MEDICAL TECHNOLOGY CO. LTD | 328420 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| YESO-MED STERILE HYPODERMIC SYRINGE & SAFETY NEEDLE | WUXI YUSHOU MEDICAL APPLIANCE CO. LTD | 328449 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| STERILE HYPODERMIC SYRINGE WITHOUT NEEDLE FOR SINGLE USE | WUXI YUSHOU MEDICAL APPLIANCE CO. LTD | 328584 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE SYRINGE WITHOUT NEEDLE, SAFETY NEEDLE, HYPODERMIC NEEDLE | ANHUI TIANKANG MEDICAL TECHNOLOGY CO. LTD | 328777 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| STERILE SYRINGE WITHOUT NEEDLE FOR SINGLE USE | JIANGSU SHENLI MEDICAL PRODUCTION CO., LTD. | 328780 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SYRINGE 3CC LUER LOCK | JIANGSU CAINA MEDICAL CO., LTD. | 328902 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NEEDLE 23G*1" | JIANGSU CAINA MEDICAL CO., LTD. | 328904 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ADI MEDICAL DYNATOUCH VINYL EXAM GLOVES | ASIA DYNAMICS INC. DBA ADI MEDICAL | 328920 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| REALTOUCH NITRILE EXAMINATION GLOVE | CHINA FINANCIAL CAPITAL MANAGEMENT CO. LTD | 329032 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NITRILE EXAM GLOVES NON-STERILE POWDER-FREE FINGERTIP TEXTURED CHEMOTHERAPY DRUG TESTED | VALIANT LLC | 329136 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPO VAN SINGLE USE NEEDLE | HINDUSTAN SYRINGES & MEDICAL DEVICES LTD. | 329194 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPO VAN SINGLE USE SYRINGE WITH NEEDLE | HINDUSTAN SYRINGES & MEDICAL DEVICES LTD. | 329210 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPO VAN SINGLE USE SYRINGE | HINDUSTAN SYRINGES & MEDICAL DEVICES LTD. | 329217 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| COMFORT TIME NITRILE SYNTHETIC VINYL EXAM GLOVES | LEKE HOLDING GROUP LIMITED | 329345 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| HYPODERMIC NEEDLE | ZHEJIANG HUAFU MEDICAL EQUIPMENT CO., LTD. | 329555 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL NITRILE EXAMINATION GLOVES (NON STERILE) | JIANGSU CHERISH MEDICAL TECHNOLOGY CO., LTD | 329556 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDICAL INFRARED THERMOMETER | KENWILL TECHNOLOGIES CORPORATION | 329624 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PRIMOCARE NITRILE EXAMINATION GLOVES | CHANGZHOU YIHUA SANITATION MATERIAL CO. LTD. | 329639 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ADVANCARE DISPOSABLE NITRILE EXAM GLOVES | INTCO MEDICAL | 329732 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ADVANCECARE SYNMAX VINYL EXAM GLOVES | INTCO MEDICAL | 329878 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| COVICHEK CLINICAL VIRAL TRANSPORT MEDIUM (CTM) | WIZCHEM CO., LTD. | 330429 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ZERO RESIDUAL SMALL VOLUME SYRINGE 0.3ML LUER LOCK WITHOUT NEEDLE AND LUER SLIP WITHOUT NEEDLE | SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO. LTD. | 330784 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ZERO RESIDUAL DISPOSABLE NEEDLE | ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. | 330787 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE SYRINGES WITH NEEDLES | SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD | 331058 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ANGIOGRAPHIC SYRINGES | SHENZHEN ANTMED CO., LTD. | 331083 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| POWDER FREE NITRILE EXAMINATION GLOVES | GUANGDONG KINGFA SCL & TECH CO. LTD | 332203 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| BRIGHT SAFE CARE MEDICAL INFRARED FOREHEAD THERMOMETER | HUNAN HONGGAO ELECTRONIC TECHNOLOGY CO. LTD. | 332647 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| STERILE HYPODERMIC 1ML SYRINGE WITH NEEDLE FOR SINGLE USE | HUNAN PINGAN MEDICAL DEVICE TECHNOLOGY CO. LTD | 332686 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| EZCARE POWDER FREE NITRILE EXAMINATION GLOVES | VIETGLOVE CORPORATION | 333287 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| STERILE HYPODERMIC NEEDLES FOR SINGLE USE | WEIGAO MEDICAL INTERNATINAL CO., LTD. | 333542 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| STERILE HYPODERMIC SYRINGES FOR SINGLE USE | WEIGAO MEDICAL INTERNATINAL CO., LTD. | 333543 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| STERILE SYRINGE SAFETY WITH NEEDLE (SINGLE USE) | GEMTIER MEDICAL (SHANGHAI) INC. | 334143 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| STERILE SYRINGE LUER SLIP | JIANGSU MICSAFE MEDICAL TECHNOLOGY CO., LTD | 334449 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NITRILE EXAM GLOVES NON-STERILE POWDER-FREE FINGERTIP TEXTURED CHEMOTHERAPY DRUG TESTED | VALIANT LLC | 334549 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDBEC STERILE SYRINGE WITH NEEDLE | ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD. | 334678 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| "LUMENA" AEROSOL MINIMIZING NIV MASK FOR ADULTS | INSPIR LABS LTD. | 335025 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NITRILE EXAMINATION GLOVES | HL RUBBER INDUSTRIES SDN BHD | 340623 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NITRILE POWDER FREE EXAMINATION GLOVES | BERGAMOT SDN BHD | 341158 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| VINYL /NITRILE SYNTHETIC EXAM GLOVES GANTS D'EXAMEN EN VINYLE /NITRILE SYNTHÉTIQUE | SHANDONG HONGXIN CHEMICAL INDUSTRY COMPANY LIMITED | 342092 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| VINYL EXAMINATION GLOVES | SHANDONG HONGXIN CHEMICAL INDUSTRY COMPANY LIMITED | 348641 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| POWDER FREE VINYL EXAMINATION GLOVES VINYLE GANTS D'EXAMEN SANS POUDRE | NATURA LIFESTYLE INC. | 353483 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| GO2VENT | VORTRAN MEDICAL TECHNOLOGY 1, INC. | 312907 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| XRAI | SYNTHESIS HEALTH INTELLIGENCE INC. | 313228 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| BIPAP A40 PRO | RESPIRONICS INC. ALSO TRADING AS PHILIPS RS NORTH AMERICA LLC | 313513 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| VX85O VENTILATOR | RESPIRONICS CALIFORNIA LLC | 313525 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| VENTILATOR | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | 313634 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| EARLYVUE VS30 VITAL SIGNS MONITOR | PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH | 313663 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PANTHEON EMERGENCY VENTILATOR BY OCALINK | OCALINK TECHNOLOGIES INC. | 313957 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| VENTWAY SPARROW | INOVYTEC MEDICAL SOLUTIONS LTD. | 314747 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ALBERTA E-VENT 1.0 "BERTIE" | EXERGY SOLUTIONS INC. | 315305 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| JENNY VENTILATION MODULE | MS WESTFALIA GMBH | 316088 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| TRILOGY EV300 | RESPIRONICS INC. ALSO TRADING AS PHILIPS RS NORTH AMERICA LLC | 316190 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| CAEAIR1 | CAE | 316333 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| CYTOSORB 300 | CYTOSORBENTS, CORPORATION | 316575 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| R SERIES RESPIRATORY INSUFFICIENCY VENTILATOR | BMC MEDICAL CO., LTD. | 316814 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| CARETAKER4 | CARETAKER MEDICAL | 320275 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SERAPH 100 MICROBIND AFFINITY BLOOD FILTER | EXTHERA MEDICAL CORPORATION | 324822 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| CARAT PRO | HOFFRICHTER GMBH | 327128 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| GENEFINDER COVID-19 PLUS REALAMP KIT | OSANG HEALTHCARE CO., LTD. | 312757 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| BIOMEME SARS-COV-2 TEST | BIOMEME INC | 312839 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SARS-COV-2 VIRUS DETECTION DIAGNOSTIC KIT (RT-QPCR METHOD) | NINGBO HEALTH GENE TECHNOLOGIES CO., LTD | 312918 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NOVEL CORONAVIRUS (2019-NCOV) NUCLEIC ACID DIAGNOSTIC KIT (PCR-FLUORESCENCE PROBING) | SANSURE BIOTECH INC. | 313162 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SMART DETECT SARS-COV-2 RRT-PCR KIT | INBIOS INTERNATIONAL INC. | 315266 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| U-TOP COVID-19 DETECTION KIT | SEASUN BIOMATERIALS INC. | 315967 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PCL COVID19 AG RAPID FIA AND PCL IMMUNOFLUORESCENCE ANALYZER PCLOK EZ | PCL INC. | 320216 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| KANTARO SEMI-QUANTITATIVE SARS-COV-2 IGG ANTIBODY KIT | KANTARO BIOSCIENCES, LLC | 320413 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| RAPID SARS-COV-2 ANTIGEN TEST CARD | XIAMEN BOSON BIOTECH CO., LTD. | 323096 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| EDI NOVEL CORONAVIRUS COVID-19 IGG AND IGM ELISA KITS | EPITOPE DIAGNOSTICS, INC. | 328086 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| AIR PRO DISPOSABLE PARTICULATE RESPIRATOR | AP MASCARLLAS SA DE CV | 322004 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ANTI-FOG FACE SHIELD | REMI KINGS PRODUCTS INC. | 322507 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ZONGDE DISPOSABLE FACE MASK | ZONGDE HEALTH CORP. | 312819 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE MASK DISPOSABLE 3-PLY | HUBEI WANLI PROTECTIVE PRODUCTS CO., LTD. | 313550 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PHOENIX SHIELD | AEROSPACE AND TELECOMMUNICATIONS ENGINEERING SUPPORT SQUADRON (ATESS) | 314023 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| VISIERE FACIALE/FACE SHIELD | ROBCO INC. | 314036 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SHIELD ME | M.E INNOVATIONS INC. | 314042 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| 1. ISOLATION GOWNS 2.PE GOWNS 3.STERILE ISOLATION GOWNS | XINLE HUABAO MEDICAL PRODUCTS CO., LTD | 314059 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| BLOUSE DE PROTECTION | NEPTON INC. | 314143 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE 10 MIL POLYETHYLENE TEREPHTHALATE FACE SHIELD (FSH) | SUPERIOR GLOVE WORKS LTD. | 314207 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| 1 SWAB | ULTRA MANUFACTURING LTD. DBA MITCHELL PLASTICS | 314374 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| GRACIOUS LIVING FACE SHIELD | GRACIOUS LIVING CORPORATION | 314442 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| RXPROTECT 4 MEDICAL HOOD | PTNR PRODUCTIONS INC. | 314863 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ICON COVID-19 FACE SHIELD | ICON DIGITAL PRODUCTIONS INC. | 315011 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ZENSHIELDS | ZEN MAKER LAB INC. | 315053 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDICAL FACE MASK | HARBIN HAOWEIWEIYE TECHNOLOGY DEVELOPMENT CO., LTD | 315497 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| RESPIRATOR KN95-V1 | SHANDONG HAIDIKE MEDICAL PRODUCTS CO.,LTD | 315553 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PROTECTIVE FACE SHIELD | SHAVER INDUSTRIES INC | 315565 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| FACE SHIELD | HIP LIK PACKAGING PRODUCTS LTD. | 315620 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PPE FACE SHIELD | SOMERVILLE MERCHANDISING INC. | 315943 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| BODY TEMPERATURE SCANNER | CANTRONIC SYSTEMS (CANADA) INC. | 315948 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDICAL FACE MASK | FOSHAN NANHAI PLUS MEDICAL CO., LTD | 316410 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL FACE MASK | FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO., LTD. | 316478 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DYNAMIC FACE SHIELD | DYNAMIC IMAGING SOLUTIONS INC. | 316709 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| CADS REPROCESSED N95 OR N95 EQUIVALENT RESPIRATOR | CDR SYSTEMS INC. | 317457 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PURISM DISPOSABLE MEDICAL MASK | CHUZHOU DADDY'S CHOICE SCIENCE AND TECHNOLOGY CO., LTD | 317655 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PAPP NS SWAB | PAPP PLASTICS AND DISTRIBUTING LTD. | 317747 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| TJM NASOPHARYNGEAL SWAB | TRONOSJET MAINTENANCE INC. | 317961 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| DISPOSABLE MEDICAL FACE MASK | HUNAN EEXI TECHNOLOGY & SERVICE CO., LTD | 317973 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SURGICAL FACE MASK(NON-STERILE) | HUNAN EEXI TECHNOLOGY & SERVICE CO., LTD | 317979 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| BK MEDICAL FACE MASK(NON-STERILE) | GUANGXI BIKANG MEDICAL DEVICE CO., LTD. DBA GUANGXI BIKANG E-COMMERCE CO., LTD | 318191 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| REUSABLE PVC FULL FACE SPLASHGUARD SHIELD | BP COMMODITIES LIMITED | 318209 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| VISI-GUARD ECO | OLYMPIC SCIENTIFIC CORP. | 319514 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| NORSLINE FACE SHIELD | NORSLINE INC. | 320134 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ARC SURGICAL RESPIRATOR | ECLIPSE INNOVATIONS INC. | 320544 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SURGICAL FACE MASK | FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO., LTD. | 320590 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| JET SWAB NASOPHARYNGEAL SWAB | TRONOSJET MAINTENANCE INC. | 320987 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| HORIZON SURGICAL RESPIRATOR | ECLIPSE INNOVATIONS INC. | 321423 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| 5 PLY SURGICAL RATED N95 FLATFOLD RESPIRATORS WITH HEADBANDS | ALPHA MEDICAL MANUFACTURING INC. | 322967 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PROFACTOR 6983 SURGICAL N95 RESPIRATOR | ADVANCED MEDICAL MANUFACTURING LTD. | 324457 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| PRO + RESPIRATOR MASK | TREBOR RX CORP. | 324815 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| MEDICAL ISOLATION EYE MASK | SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD | 327638 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| KROSS DIRECT N95 SURGICAL RESPIRATOR | 2109971 ONTARIO INC. DBA KROSS DIRECT | 327682 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| ZENGUARD DISPOSABLE FACE MASK WITH ANTI-MICROBIAL TECHNOLOGY | TREBOR RX CORP. | 329587 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| KROSS DIRECT N95P PARTICULATE RESPIRATOR | 2109971 ONTARIO INC. DBA KROSS DIRECT | 330068 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| RHINOSTIC AUTOMATED NASAL SWAB | RHINOSTICS INC. | 344685 | 2023-07-27 | Did not meet additional requirements to transition under Part 1.1 |
| SAL6830 SARS-COV-2 SALIVA TESTING SYSTEM (MODEL:SCFMA) | MICROGEM U.S., INC. | 341410 | 2023-11-30 | Did not submit requested information. |
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