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SARS-CoV-2/M.pneumoniae IgG/IgM Combo Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref VISM-737
Identity
- Trade Name
- SARS-CoV-2/M.pneumoniae IgG/IgM Combo Rapid Test EUDAMED
- Device Name
- SARS-CoV-2/M.pneumoniae IgG/IgM Combo Rapid Test EUDAMED
- Model / Reference
- VISM-737 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VISM-737UT EUDAMED
- Basic UDI-DI
- B-VISM-737UT EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
SARS-CoV-2/M.pneumoniae IgG/IgM 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-VISM-737UT | 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 (1)
- EUDAMED fa10b0a3-d0d9-499e-a5d5-04f4802e6c53 61 fields · synced Oct 7, 2026