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Hepatocellular Carcinoma Methylation ddPCR Kit
EUDAMEDClass C (EU MDR)
Ref GACP0001
Identity
- Device Name
- Hepatocellular Carcinoma Methylation ddPCR Kit EUDAMED
- Model / Reference
- GACP0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979822870457 EUDAMED
- Basic UDI-DI
- 697982287GACP00018C EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- France 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
Hepatocellular Carcinoma Methylation ddPCR Kit by Cellomics (Shenzhen) Limited — Class C — 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 | 697982287GACP00018C | Class C | 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 24088951-6b7b-408e-a444-4a53ef026281 61 fields · synced Jun 18, 2026