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Cowingene STI Multiplex Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref ST11021V, ST11022U, ST13021W, ST13022U, ST14021X, ST14022X, ST14023W, ST15023P
Identity
- Trade Name
- Cowingene STI Multiplex Detection Kit EUDAMED
- Device Name
- Cowingene STI Multiplex Detection Kit EUDAMED
- Model / Reference
- ST11021V, ST11022U, ST13021W, ST13022U, ST14021X, ST14022X, ST14023W, ST15023P EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ST11MZ EUDAMED
- Basic UDI-DI
- B-ST11MZ 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 STI Multiplex Detection Kit by Taizhou Cowingene Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-ST11MZ | 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 7315ef6c-d7d9-43c9-bc3b-4a17b2e321a8 61 fields · synced Jun 18, 2026
- EUDAMED 7315ef6c-d7d9-43c9-bc3b-4a17b2e321a8-1 61 fields · synced Jun 10, 2026