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COVID-19 IgM/IgG / SARS-CoV-2 IgM/IgG
EUDAMEDClass IVD General (EU MDR)
Ref VID35
Identity
- Trade Name
- COVID-19 IgM/IgG / SARS-CoV-2 IgM/IgG EUDAMED
- Device Name
- COVID-19 IgM/IgG Rapid Test / SARS-CoV-2 IgM/IgG Rapid Test EUDAMED
- Model / Reference
- VID35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VID3532 EUDAMED
- Basic UDI-DI
- B-VID3532 EUDAMED
- EMDN Code
- W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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 IgM/IgG / SARS-CoV-2 IgM/IgG 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-VID3532 | 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 dc66c522-0707-4620-a12b-166dd1d699e4 61 fields · synced Oct 6, 2026