Identity
- Trade Name
- CryoStore Freezing Bags EUDAMED
- Device Name
- CryoStore Freezing Bags EUDAMED
- Model / Reference
- CS250S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20816203020967 EUDAMED
- Basic UDI-DI
- B-20816203020967 EUDAMED
- EMDN Code
- B0103 MEDULLARY BLOOD COLLECTION, PURIFICATION, CRYOPRESERVATION BAGS AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria 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-20816203020967 | Class IIa | Active |
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Manufacturer
- Manufacturer
- OriGen Biomedical Inc.
- EUDAMED SRN
- US-MF-000018098
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED ec5c0bb3-62d0-41a6-8253-0c99b9aaba68 61 fields · synced Jun 18, 2026