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Circulating epithelial cell detection kit
EUDAMEDClass C (EU MDR)
Ref IFCP0100Ref IFCP0101
Identity
- Device Name
- Circulating epithelial cell detection kit EUDAMED
- Model / Reference
- IFCP0100 EUDAMEDIFCP0101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979822870273 EUDAMED06979822870013 EUDAMED
- Basic UDI-DI
- 697982287IFCP0100CA EUDAMED697982287IFCP0101CC EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass A EUDAMED
- Market of Registration
- France EUDAMEDGermany 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
Yes
EUDAMED
Circulating epithelial cell detection 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 | 697982287IFCP0100CA | 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 (2)
- EUDAMED ec7acf9d-f2a7-4b79-bed1-9c6117958834 61 fields · synced Jul 27, 2026
- EUDAMED 62c2be02-8bf8-4ff1-97ac-202ac6510468 61 fields · synced May 17, 2026