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COVID-19/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref RV-B55aRef IABC-1033
Identity
- Trade Name
- COVID-19/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test EUDAMEDInfluenza A&B/COVID-19 Antigen Combo Rapid Test EUDAMED
- Device Name
- COVID-19/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test EUDAMEDInfluenza A&B/COVID-19 Antigen Combo Rapid Test EUDAMED
- Model / Reference
- RV-B55a EUDAMEDIABC-1033 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-RV-B55aYV EUDAMED06974785750389 EUDAMED
- Basic UDI-DI
- B-RV-B55aYV EUDAMEDB-06974785750389 EUDAMED
- EMDN Code
- W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC EUDAMEDW0105090601 CORONAVIRUS / INFLUENZA - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
No
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
COVID-19/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test by Hangzhou Aichek Medical Technology 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-RV-B55aYV | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 19ada59c-29be-4cfe-bdd6-a4e1ecb7036c 61 fields · synced Oct 6, 2026
- EUDAMED f5b6c61a-6780-4c19-b7bc-26536190ecd1 61 fields · synced Jul 14, 2026