Identity
- Device Name
- Cell Recognizer EUDAMED
- Model / Reference
- CVCP0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979822870228 EUDAMED
- Basic UDI-DI
- 697982287CVCP0001H5 EUDAMED
- EMDN Code
- W02020199 CELL COUNTING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Cell Recognizer by Cellomics (Shenzhen) Limited — 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 | 697982287CVCP0001H5 | Class A | Active |
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Manufacturer
- Manufacturer
- Cellomics (Shenzhen) Limited
- EUDAMED SRN
- CN-MF-000028334
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 157ab3a8-dabd-42ec-9c01-4d90b32b78e9 61 fields · synced Jul 11, 2026