Files are large and may take some time to open.
Note: You will need the Adobe Acrobat reader to download and view these items. You may obtain the free Adobe Acrobat reader here.
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
ISO 13485-2003 Certificate - Plasco, a Division of Microtek Medical
2018 FDA Facility Registration - Acuna, MX
2018 FDA Facility Registration - Alpharetta, GA
2018 FDA Facility Registration - Columbus, MS
2018 FDA Facility Registration - Jacksonville, FL
2018 FDA Facility Registration - LaRomana, DR
2018 FDA Facility Registration - Santo Domingo (Las Americas) DR
2018 FDA Facility Registration - Malta, FR
2018 FDA Facility Registration - Tyler, TX
2018 FDA Facility Registration - Varsseveld, NL
2018 FDA Facility Registration - Zutphen, NL
Japanese registration certificate of foreign medical device manufacture – La Romana
Japanese Accreditation of Foreign Manufacturer - Columbus Facility
Japanese Accreditation of Foreign Manufacturer - Malta Facility
Louisiana Board of Wholesale 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