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 510(k) number: K021702
- CryoStore Multi-Chamber 510(k) number: BK180278