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Cowingene Enterovirus Universal, EV71 and CoxA16 Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref GI04021X, GI04022X, GI04023W
Identity
- Trade Name
- Cowingene Enterovirus Universal, EV71 and CoxA16 Detection Kit EUDAMED
- Device Name
- Cowingene Enterovirus Universal, EV71 and CoxA16 Detection Kit EUDAMED
- Model / Reference
- GI04021X, GI04022X, GI04023W EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GI04HR EUDAMED
- Basic UDI-DI
- B-GI04HR EUDAMED
- EMDN Code
- W0105070504 GASTROINTESTINAL INFECTIONS - MULTIPLEX 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 Enterovirus Universal, EV71 and CoxA16 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-GI04HR | 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 5a24aa62-fe5f-414f-9f9a-cdcea5fbb8ef 61 fields · synced Jul 9, 2026
- EUDAMED 5a24aa62-fe5f-414f-9f9a-cdcea5fbb8ef-1 61 fields · synced Jun 9, 2026