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SARS-CoV-2/Influenza A+B/RSV Ag Combo Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref VISIR-737Model VISIR
Identity
- Trade Name
- SARS-CoV-2/Influenza A+B/RSV Ag Combo Rapid Test EUDAMED
- Device Name
- SARS-CoV-2/Influenza A+B/RSV Ag Combo Rapid Test EUDAMED
- Model / Reference
- VISIR EUDAMEDVISIR-737 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970221768949 EUDAMED06937339209474 EUDAMED
- Basic UDI-DI
- B-06970221768949 EUDAMEDB-06937339209474 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMEDItaly 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
SARS-CoV-2/Influenza A+B/RSV Ag Combo Rapid Test by VivaChek Biotech (Hangzhou) 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-06970221768949 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012160
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 27b0c021-d472-4ed9-84ca-0f534988caf3 61 fields · synced Oct 6, 2026
- EUDAMED cb154667-5edc-48a1-b342-a224df8afa15 61 fields · synced Jul 29, 2026