Identity
- Device Name
- CWseq Fast DNA Library Prep Kit EUDAMED
- Model / Reference
- CW3045M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974454728299 EUDAMED
- Basic UDI-DI
- 697445472V25001W3045JB EUDAMED
- Direct Marketing DI
- 06974454728299 EUDAMED
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
CWseq Fast DNA Library Prep 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 | 697445472V25001W3045JB | 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 0c8ee795-1ba3-46ae-a931-56450fbda105 61 fields · synced Jul 14, 2026