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Sample Separation Media
EUDAMEDClass A (EU MDR)
Ref CTCP0006Ref CTCP0007Ref CTCP0003
Identity
- Device Name
- Sample Separation Media EUDAMED
- Model / Reference
- CTCP0006 EUDAMEDCTCP0007 EUDAMEDCTCP0003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979822870167 EUDAMED06979822870174 EUDAMED06979822870082 EUDAMED
- Basic UDI-DI
- 697982287CTCP0006GD EUDAMED697982287CTCP0007GF EUDAMED697982287CTCP0003G7 EUDAMED
- EMDN Code
- W01030199 HAEMATOLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class 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
No
EUDAMEDEUDAMED
Sample Separation Media 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 | 697982287CTCP0006GD | 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 (3)
- EUDAMED a23c16d2-4b86-43fb-9819-13a82df91624 61 fields · synced Jul 25, 2026
- EUDAMED 28936d8b-e558-4966-8d58-04f30a0d33a0 61 fields · synced May 18, 2026
- EUDAMED 0e24a930-b63b-4d1d-9478-c1364f49d5d3 61 fields · synced May 18, 2026