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Cell-Free DNA Storage Tube
EUDAMEDClass A (EU MDR)
Ref CWX006MModel CWX005M/CWX006M/CWX007M/CWX008MRef CWX003MRef CWX008MModel CWX007M/CWX008MRef CWX005MRef CWX006M-HRef CWX004M
Identity
- Device Name
- Cell-Free DNA Storage Tube EUDAMEDCell-Free DNA Storage Tube(PET) EUDAMEDCell-Free DNA Storage Tube(PET, non-sterile) EUDAMED
- Model / Reference
- CWX005M/CWX006M/CWX007M/CWX008M EUDAMEDCWX006M EUDAMEDCWX003M EUDAMEDCWX007M/CWX008M EUDAMEDCWX008M EUDAMEDCWX005M EUDAMEDCWX006M-H EUDAMEDCWX004M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974454727759 EUDAMED06974454727179 EUDAMED06974454727551 EUDAMED06974454727773 EUDAMED06974454727742 EUDAMED06974454727926 EUDAMED06974454727186 EUDAMED
- Basic UDI-DI
- 697445472V22004X005X0088H EUDAMED697445472V21009X003X0049Z EUDAMED697445472V22001X007X00872 EUDAMED697445472V23005X00667 EUDAMED
- Direct Marketing DI
- 06974454727759 EUDAMED06974454727179 EUDAMED06974454727551 EUDAMED06974454727773 EUDAMED06974454727742 EUDAMED06974454727926 EUDAMED06974454727186 EUDAMED
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
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 (7)
- EUDAMED 6301a562-5b0a-4acc-84c2-fb99b624cc31 61 fields · synced Jul 20, 2026
- EUDAMED c875950c-326b-48eb-8dcb-fd149cf07d9d 61 fields · synced May 16, 2026
- EUDAMED 3884d6b6-d489-4f76-9a80-07d3a26b9acb 61 fields · synced May 17, 2026
- EUDAMED 5b77b6a4-232e-49b5-bc74-066b882591ec 61 fields · synced May 17, 2026
- EUDAMED c2aa7a7c-ea0d-4df8-819e-0d02d52c8612 61 fields · synced May 17, 2026
- EUDAMED 55e24643-ba88-49fe-9a78-4e404b76f9eb 61 fields · synced May 18, 2026
- EUDAMED 6c9552cb-11f7-4cf6-b4a3-0cea0e6c945a 61 fields · synced May 19, 2026