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Magbead Viral DNA/RNA Kit
EUDAMEDClass A (EU MDR)
Ref CWX104S-BRModel CWX102S/CWX103S/CWX103S-BR/CWX103S-ZY/CWX103S-SLD/CWX104S/CWX104S-BR/CWX104S-ZY/CWX104S-M
Identity
- Device Name
- Magbead Viral DNA/RNA Kit EUDAMED
- Model / Reference
- CWX102S/CWX103S/CWX103S-BR/CWX103S-ZY/CWX103S-SLD/CWX104S/CWX104S-BR/CWX104S-ZY/CWX104S-M EUDAMEDCWX104S-BR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974454727148 EUDAMED
- Basic UDI-DI
- 697445472V21004X102-104VG EUDAMED
- Direct Marketing DI
- 06974454727148 EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS 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
Category: Nucleic acid extraction/isolation kit IVD
Magbead Viral DNA/RNA Kit by Jiangsu CoWin Biotech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 | 697445472V21004X102-104VG | 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 ba9a74ff-c384-40d8-ac37-27e6215471d4 61 fields · synced Jun 18, 2026