OriGen Biomedical is ISO 13485 Certified, plus our medical devices have received marketing clearance from the FDA, are CE-marked, and are approved in many other markets worldwide. Please see the individual product pages for the registration of each device.

Our 510K numbers are below:
  • CryoStore 510(k) number: BK030036
  • PermaLife and CryoBag 510(k) number: K021702
  • CryoStore Multi-Chamber 510(k) number: BK180278

LINKS

CERTIFICATES

HEALTH CANADA MDL DATABASE

SYMBOL GLOSSARY

ISO 13485 Certificate

MDSAP Registration