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Cowingene Dengue Virus, Zika Virus and Chikungunya Virus Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref FE01021X, FE01022X, FE01023W
Identity
- Trade Name
- Cowingene Dengue Virus, Zika Virus and Chikungunya Virus Detection Kit EUDAMED
- Device Name
- Cowingene Dengue Virus, Zika Virus and Chikungunya Virus Detection Kit EUDAMED
- Model / Reference
- FE01021X, FE01022X, FE01023W EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FE01GQ EUDAMED
- Basic UDI-DI
- B-FE01GQ EUDAMED
- EMDN Code
- W0105070506 TROPICAL FEVER - 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 Dengue Virus, Zika Virus and Chikungunya Virus 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-FE01GQ | 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 28f1745f-efe9-422e-b075-49cc18058846 61 fields · synced Oct 7, 2026
- EUDAMED 28f1745f-efe9-422e-b075-49cc18058846-1 61 fields · synced Jun 11, 2026