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. Please see the individual product pages for the registration of each device. The 510K numbers are below:
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
Additional Accreditation Information:
Our labels use the symbol glossary found here.