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Cowingene SARS-CoV-2 & Influenza A/B Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref RP11021X, RP11022X, RP11023W
Identity
- Trade Name
- Cowingene SARS-CoV-2 & Influenza A/B Detection Kit EUDAMED
- Device Name
- Cowingene SARS-CoV-2 & Influenza A/B Detection Kit EUDAMED
- Model / Reference
- RP11021X, RP11022X, RP11023W EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-RP11M6 EUDAMED
- Basic UDI-DI
- B-RP11M6 EUDAMED
- EMDN Code
- W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - 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 SARS-CoV-2 & Influenza A/B 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-RP11M6 | 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 (3)
- EUDAMED 08f7d555-3b96-48fb-aeec-0a46a62693d2 61 fields · synced Jun 18, 2026
- EUDAMED 08f7d555-3b96-48fb-aeec-0a46a62693d2-1 61 fields · synced Jun 10, 2026
- EUDAMED 08f7d555-3b96-48fb-aeec-0a46a62693d2-2 61 fields · synced Jun 10, 2026