Regulatory

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 510(k) numbers are below:

• CryoStore Bag 510(k) Number: BK030036
• PermaLife™ Bag 510(k) Number: K021702
• CryoStore Multi-Chamber Bag 510(k) Number: BK180278

LINKS

CERTIFICATES