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Nucleic Acid Release Reagent
EUDAMEDClass A (EU MDR)
Ref CWX013H-PModel CWX013M/CWX013L/CWX013H/CWX013L-P/CWX013H-P
Identity
- Device Name
- Nucleic Acid Release Reagent EUDAMED
- Model / Reference
- CWX013M/CWX013L/CWX013H/CWX013L-P/CWX013H-P EUDAMEDCWX013H-P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974454727278 EUDAMED
- Basic UDI-DI
- 697445472V21002X0133V EUDAMED
- Direct Marketing DI
- 06974454727278 EUDAMED
- EMDN Code
- W0104010299 MEDIA IN TUBES - 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
Nucleic Acid Release Reagent 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 | 697445472V21002X0133V | 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 00ac9ccc-4e42-401e-aedb-5e3c709038d4 61 fields · synced Jun 18, 2026