Origen Regulatory Status

Regulatory Status

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

CryoStore: Click here to see the FDA marketing clearance of CryoStore Bags from CBER.

PermaLife and Cryobag: Click here to see the FDA marketing clearance of the Cryobag and Permalife from CDRH.

Origen ECLS catheter: Click here to see the FDA marketing clearance of the Origen ECMO cannula from CDRH.

ISO 13485 Certificate: Click here to download a PDF copy of our ISO 13485 Certificate

CE Certificate: Click here to download a PDF copy of our CE Certificate.