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Cell Preservation Solution
EUDAMEDClass A (EU MDR)
Ref CPS-025-20Model CPS-025-10Ref CPS-025-10
Identity
- Trade Name
- Cell Preservation Solution EUDAMED
- Device Name
- Cell Preservation Solution EUDAMED
- Model / Reference
- CPS-025-10 EUDAMEDCPS-025-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973873141054 EUDAMED06973873141047 EUDAMED
- Basic UDI-DI
- 697387314CPSV9 EUDAMED
- Direct Marketing DI
- 06973873141054 EUDAMED06973873141047 EUDAMED
- EMDN Code
- W01040404 OTHER TISSUE CULTURE ADDITIVES AND SOLUTIONS EUDAMED
Classification
- Device Class
- Class A 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Cell Preservation Solution by Hangzhou Dalton BioSciences, 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 | 697387314CPSV9 | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Dalton BioSciences, Ltd.
- EUDAMED SRN
- CN-MF-000036196
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (2)
- EUDAMED b76e9e8e-7602-4386-8feb-a928993fa69b 61 fields · synced Jul 15, 2026
- EUDAMED c732f5cc-d6f8-406d-9406-8ca42382acc6 61 fields · synced May 18, 2026