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Single Cell WGA Kit
EUDAMEDClass A (EU MDR)
Ref CWX401MModel CWX401S/MRef CWX401S
Identity
- Device Name
- Single Cell WGA Kit EUDAMED
- Model / Reference
- CWX401S/M EUDAMEDCWX401M EUDAMEDCWX401S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974454727940 EUDAMED06974454727933 EUDAMED
- Basic UDI-DI
- 697445472V23004X40166 EUDAMED
- Direct Marketing DI
- 06974454727940 EUDAMED06974454727933 EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER 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
Yes
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
Single Cell WGA Kit 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 | 697445472V23004X40166 | 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 (2)
- EUDAMED a94120ec-fbe3-46e7-aaee-f1ad68bbcd92 61 fields · synced Aug 3, 2026
- EUDAMED b6ed6812-6dd5-4714-8692-b5244ef1e422 61 fields · synced May 18, 2026