Identity
- Trade Name
- CryoPur™ Solutions EUDAMED
- Device Name
- CP-100 EUDAMED
- Model / Reference
- CP-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10816203022544 EUDAMED
- Basic UDI-DI
- B-10816203022544 EUDAMED
- EMDN Code
- B06 CELLULAR OR BIOLOGICAL MANIPULATION DEVICES 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
CryoPur™ Solutions 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-10816203022544 | 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 471890ff-b331-4894-ab5a-7b9d251f43a6 61 fields · synced Jun 18, 2026