Identity
- Trade Name
- Cell Preservation Solution EUDAMED
- Device Name
- Cell Preservation Solution EUDAMED
- Model / Reference
- A、B、C、D EUDAMEDCP-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970413352437 EUDAMED
- Basic UDI-DI
- 697041335YGR1001EU7Q EUDAMED
- EMDN Code
- W05020199 SAMPLES TRANSPORT, CONTAINERS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Cell Preservation Solution by Hangzhou Yiguoren Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697041335YGR1001EU7Q | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Yiguoren Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000003616
- Authorised Representative
- BioDomi GmbH DE-AR-000016611
Sources (1)
- EUDAMED a3adbcf1-64e5-477a-a6cd-53d4b1de08a5 61 fields · synced Oct 6, 2026