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COVID-19&Influenza A+B Antigen Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref COV/FLU-B35aRef COVID-19-B02
Identity
- Trade Name
- COVID-19&Influenza A+B Antigen Rapid Test EUDAMEDCOVID-19 Antigen Rapid Test EUDAMED
- Device Name
- COVID-19&Influenza A+B Antigen Rapid Test EUDAMEDCOVID-19 Antigen Rapid Test EUDAMED
- Model / Reference
- COV/FLU-B35a EUDAMEDCOVID-19-B02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-COV/FLU-B35aM3 EUDAMEDD-COVID-19-B026L EUDAMED
- Basic UDI-DI
- B-COV/FLU-B35aM3 EUDAMEDB-COVID-19-B026L EUDAMED
- EMDN Code
- W0105090601 CORONAVIRUS / INFLUENZA - RT & POC EUDAMEDW0105090501 CORONAVIRUS ANTIGEN (AG) - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
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 Antigen 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-COV/FLU-B35aM3 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 4b62d1f2-5da2-4f99-a1c5-e3c3496fc1d2 61 fields · synced Oct 1, 2026
- EUDAMED cde60369-a403-4f53-bcd6-6bf0a31c0496 61 fields · synced Oct 1, 2026