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RSV/Influenza A+B Combo Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref VIRI-737Model VIRIRef VIFLab-702Model VIFLabRef VIARI-747Model VIARIRef VIRI-737-001
Identity
- Trade Name
- RSV/Influenza A+B Combo Rapid Test EUDAMEDInfluenza A+B Rapid Test EUDAMEDAdenovirus/RSV/Influenza A+B Combo Rapid Test EUDAMED
- Device Name
- RSV/Influenza A+B Combo Rapid Test EUDAMEDInfluenza A+B Rapid Test EUDAMEDAdenovirus/RSV/Influenza A+B Combo Rapid Test EUDAMED
- Model / Reference
- VIRI EUDAMEDVIRI-737 EUDAMEDVIFLab EUDAMEDVIFLab-702 EUDAMEDVIARI EUDAMEDVIARI-747 EUDAMEDVIRI-737-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937339204059 EUDAMED06937339205391 EUDAMED06937339205810 EUDAMED06937339210265 EUDAMED
- Basic UDI-DI
- B-06937339204059 EUDAMEDB-06937339205391 EUDAMEDB-06937339205810 EUDAMEDB-06937339210265 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMEDW0105099004 INFLUENZA A AND /OR B - RT & POC 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
RSV/Influenza A+B Combo Rapid Test by VivaChek Biotech (Hangzhou) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06937339204059 | 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 (4)
- EUDAMED 4f79a944-638c-423d-8880-32dda35c8fcd 61 fields · synced Oct 6, 2026
- EUDAMED b179896a-7e52-40f7-a215-89e928ca2f32 61 fields · synced May 17, 2026
- EUDAMED 32d2b4f2-2aff-47b4-9ef5-0e76d987f4e1 61 fields · synced May 18, 2026
- EUDAMED ff061ffb-7947-4f4d-9144-facf33d14bd0 61 fields · synced Jul 21, 2026