Identity
- Trade Name
- CryoStore Freezing Bags EUDAMED
- Device Name
- CS50M3 EUDAMED
- Model / Reference
- CS50M3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20816203021339 EUDAMED
- Basic UDI-DI
- B-20816203021339 EUDAMED
- EMDN Code
- B0103 MEDULLARY BLOOD COLLECTION, PURIFICATION, CRYOPRESERVATION BAGS AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CryoStore Freezing Bags by OriGen Biomedical, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-20816203021339 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OriGen Biomedical Inc.
- EUDAMED SRN
- US-MF-000018098
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED e3b7142e-e1fb-471a-93fa-c32cdd55def2 61 fields · synced Jun 18, 2026