Global Certifications

Global Healthcare Certifications

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CAN/CSA ISO 13485:2003 Certificate

EC Certification Annex II with Product List

EC Certification Annex V with Product List

EC Certification Annex V - 1s - Malta

EC Certification Annex V - 11a - Malta

EC Certification Annex V - 11a - Zutphen

EC Certification Annex V - 1s - Zutphen

ISO 13485:2012 + AC:2012 Certificate – Alpharetta, Columbus, DR, Jacksonville and St. Paul

EN ISO 13485:2012 - Malta

EN ISO 13485:2012 - Zutphen

ISO 13485-2003 Certificate - Plasco, a Division of Microtek Medical

2017 FDA Facility Registration - Acuna, MX

2017 FDA Facility Registration - Alpharetta, GA

2017 FDA Facility Registration - Columbus, MS

2017 FDA Facility Registration - Jacksonville, FL

2017 FDA Facility Registration - LaRomana, DR

2017 FDA Facility Registration - Las Americas, DR

2017 FDA Facility Registration - Malta, FR

2017 FDA Facility Registration - Tyler, TX

2017 FDA Facility Registration - Varsseveld, NL

2017 FDA Facility Registration - Zutphen, NL

Japanese Accreditation of Foreign Manufacturer - DR Facility

Japanese Accreditation of Foreign Manufacturer - Columbus Facility

Japanese Accreditation of Foreign Manufacturer - Malta Facility

Japanese Accreditation of Foreign Manufacturer - Columbus Facility

Japanese Accreditation of Foreign Manufacturer - Malta Facility

Japanese Accreditation of Foreign Manufacturer - Columbus Facility

Japanese Accreditation of Foreign Manufacturer - Malta Facility

Japanese Accreditation of Foreign Manufacturer - Columbus Facility

Japanese Accreditation of Foreign Manufacturer - Malta Facility

Louisiana Board of Wholesales Drug Distributors - Jacksonville Facility

Louisiana Board of Wholesale Drug Distributors - Columbus Facility

Texas Department of Health Certificate - Microtek Medical, Tyler, TX

Medical Device Establishment Registration - Canada