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Cowingene 14 Kinds of Sexually Transmitted Infection Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref ST01021V, ST01022U
Identity
- Trade Name
- Cowingene 14 Kinds of Sexually Transmitted Infection Detection Kit EUDAMED
- Device Name
- Cowingene 14 Kinds of Sexually Transmitted Infection Detection Kit EUDAMED
- Model / Reference
- ST01021V, ST01022U EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ST01MW EUDAMED
- Basic UDI-DI
- B-ST01MW EUDAMED
- EMDN Code
- W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Cowingene 14 Kinds of Sexually Transmitted Infection Detection Kit by Taizhou Cowingene Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-ST01MW | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Taizhou Cowingene Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000042619
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 3c08fa27-725b-4cc8-9b47-590a98bbb4f4 61 fields · synced Oct 5, 2026
- EUDAMED 3c08fa27-725b-4cc8-9b47-590a98bbb4f4-1 61 fields · synced Jun 10, 2026