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VivaDiag Monkeypox Virus IgM/IgG Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref VIMV-426Model VIMV
Identity
- Trade Name
- VivaDiag Monkeypox Virus IgM/IgG Rapid Test EUDAMEDMonkeypox Virus IgM/IgG Rapid Test EUDAMED
- Device Name
- VivaDiag Monkeypox Virus IgM/IgG Rapid Test EUDAMEDMonkeypox Virus IgM/IgG Rapid Test EUDAMED
- Model / Reference
- VIMV-426 EUDAMEDVIMV EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VIMV-426UU EUDAMED06937339209412 EUDAMED06937339207500 EUDAMED
- Basic UDI-DI
- B-VIMV-426UU EUDAMEDB-06937339209412 EUDAMEDB-06937339207500 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
VivaDiag Monkeypox Virus IgM/IgG 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-VIMV-426UU | 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 (3)
- EUDAMED 4207a554-1d32-43ff-b3a1-15324d6dbf7b 61 fields · synced Oct 6, 2026
- EUDAMED 8e3f6ce2-4ccc-43d9-928f-951d92ffca86 61 fields · synced Aug 4, 2026
- EUDAMED 6038babf-38f2-4e91-be9c-c0c1d61dfc9e 61 fields · synced Aug 4, 2026