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Cowingene HPV 28 Genotyping Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref HP04021V, HP04022S
Identity
- Trade Name
- Cowingene HPV 28 Genotyping Detection Kit EUDAMED
- Device Name
- Cowingene HPV 28 Genotyping Detection Kit EUDAMED
- Model / Reference
- HP04021V, HP04022S EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-HP04K3 EUDAMED
- Basic UDI-DI
- B-HP04K3 EUDAMED
- EMDN Code
- W0105041004 FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - 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 HPV 28 Genotyping 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-HP04K3 | 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 81d6db99-0d1f-4268-ae7d-51c1a89ec28e 61 fields · synced Jul 28, 2026
- EUDAMED 81d6db99-0d1f-4268-ae7d-51c1a89ec28e-1 61 fields · synced Jun 9, 2026