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SARS-CoV-2, Flu A&B Antigen, RSV, ADV, and MP Combined Detection Kit (Latex Met…
EUDAMEDClass IVD General (EU MDR)
Ref MY02029Q
Identity
- Trade Name
- SARS-CoV-2, Flu A&B Antigen, RSV, ADV, and MP Combined Detection Kit (Latex Method) EUDAMED
- Device Name
- SARS-CoV-2, Flu A&B Antigen, RSV, ADV, and MP Combined Detection Kit (Latex Method) EUDAMED
- Model / Reference
- MY02029Q EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-MY02MF EUDAMED
- Basic UDI-DI
- B-MY02MF 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
A comprehensive medical device directory entry for the SARS-CoV-2, Flu A&B Antigen, RSV, ADV, and MP Combined Detection Kit (Latex Method), providing detailed information on its features, compliance, and regulatory status.
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-MY02MF | 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 (1)
- EUDAMED 01b4210c-a4aa-4b92-b573-28d3bb670330 61 fields · synced Oct 6, 2026