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Cell-Free DNA Storage Tube
EUDAMEDClass A (EU MDR)
Ref CWX007MModel CWX005M/CWX006M/CWX007M/CWX008M
Identity
- Device Name
- Cell-Free DNA Storage Tube EUDAMED
- Model / Reference
- CWX005M/CWX006M/CWX007M/CWX008M EUDAMEDCWX007M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974454727766 EUDAMED
- Basic UDI-DI
- 697445472V22004X005X0088H EUDAMED
- Direct Marketing DI
- 06974454727766 EUDAMED
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Cell-Free DNA Storage Tube by Jiangsu CoWin Biotech Co., 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 | 697445472V22004X005X0088H | Class A | Active |
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Manufacturer
- Manufacturer
- Jiangsu CoWin Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008981
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 390d4537-e222-4a7b-be5d-b2ffea95c100 61 fields · synced Jun 18, 2026