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Magbead Viral DNA/RNA Kit
EUDAMEDClass A (EU MDR)
Ref CWX104S-M Model CWX102S/CWX103S/CWX103S-BR/CWX103S-ZY/CWX103S-SLD/CWX104S/CWX104S-BR/CWX104S-ZY/CWX104S-M Ref CWX103S-BRRef CWX104S-ZYRef CWX104SRef CWX102SRef CWX103S-SLDRef CWX103S
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-M EUDAMEDCWX103S-BR EUDAMEDCWX104S-ZY EUDAMEDCWX104S EUDAMEDCWX102S EUDAMEDCWX103S-SLD EUDAMEDCWX103S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974454727162 EUDAMED06974454727100 EUDAMED06974454727155 EUDAMED06974454727131 EUDAMED06974454727087 EUDAMED06974454727124 EUDAMED06974454727094 EUDAMED
- Basic UDI-DI
- 697445472V21004X102-104VG EUDAMED
- Direct Marketing DI
- 06974454727162 EUDAMED06974454727100 EUDAMED06974454727155 EUDAMED06974454727131 EUDAMED06974454727087 EUDAMED06974454727124 EUDAMED06974454727094 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
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
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- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
- ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- 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 (7)
- EUDAMED 667364ba-79e8-46b5-93b0-5e325872fb12 61 fields · synced Jul 21, 2026
- EUDAMED 9e456e7a-229d-4ced-a308-641baa09e48a 61 fields · synced May 17, 2026
- EUDAMED dcfa8ec3-fabe-4e59-a8a6-1f1752eb10e4 61 fields · synced May 17, 2026
- EUDAMED b743fc03-4749-40a0-afff-3859916bdf53 61 fields · synced May 18, 2026
- EUDAMED 420534e7-dae4-457f-9131-770577a0a2ea 61 fields · synced May 18, 2026
- EUDAMED 45495882-5f01-4c3c-9c88-f2d28eed94eb 61 fields · synced May 18, 2026
- EUDAMED 0b9189ee-fe13-4299-adc8-8216b14e88d1 61 fields · synced May 19, 2026