Accreditation

The quality of our products and manufacturing processes is paramount at OriGen. We are ISO 13485 Certified, plus our medical devices have received marketing clearance from FDA, are CE-marked and are generally approved for use worldwide.

CryoStore: 510(k) number: BK030036

PermaLife and CryoBag: 510(k) number: K021702

OriGen ECLS catheter: 510(k) number: K003288

OriGen Reinforced Dual Lumen Cannula: 510(k) number: K113869

PVC: 510(k) number: BK140116 

FDA Website

FDA Establishment Registration & Device Listing PDF    

ISO 13485 Certificate 

CE Certificate