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SARS-CoV-2, Influenza A&B Antigen Combined Detection Kit (Immunochromatography)
EUDAMEDClass IVD General (EU MDR)
Ref MY01029Q1, MY01029Q2
Identity
- Trade Name
- SARS-CoV-2, Influenza A&B Antigen Combined Detection Kit (Immunochromatography) EUDAMED
- Device Name
- SARS-CoV-2, Influenza A&B Antigen Combined Detection Kit (Immunochromatography) EUDAMED
- Model / Reference
- MY01029Q1, MY01029Q2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-MY01MD EUDAMED
- Basic UDI-DI
- B-MY01MD EUDAMED
- EMDN Code
- W0105090601 CORONAVIRUS / INFLUENZA - RT & POC 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
SARS-CoV-2, Influenza A&B Antigen Combined Detection Kit (Immunochromatography) by Taizhou Cowingene Biotech Co., Ltd. — Class IVD General — IVDD — listed in…
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-MY01MD | 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 c9ef26a3-7101-4900-9f10-b370a05ee702 61 fields · synced Oct 6, 2026
- EUDAMED c9ef26a3-7101-4900-9f10-b370a05ee702-1 61 fields · synced Jun 10, 2026