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Cowingene Group B Streptococcus Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref ST06011X, ST06012X, ST06013W
Identity
- Trade Name
- Cowingene Group B Streptococcus Detection Kit EUDAMED
- Device Name
- Cowingene Group B Streptococcus Detection Kit EUDAMED
- Model / Reference
- ST06011X, ST06012X, ST06013W EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ST06N8 EUDAMED
- Basic UDI-DI
- B-ST06N8 EUDAMED
- EMDN Code
- W0105011104 STREP. B DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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 Group B Streptococcus 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-ST06N8 | 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 fe7a8415-e96a-4841-858f-5e6f30c76de3 61 fields · synced Jun 18, 2026
- EUDAMED fe7a8415-e96a-4841-858f-5e6f30c76de3-1 61 fields · synced Jun 10, 2026