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COVID-19 IgG/IgM FIA Test (Serum/Plasma)
EUDAMEDClass IVD General (EU MDR)
Ref COV Ab-3012F
Identity
- Trade Name
- COVID-19 IgG/IgM FIA Test (Serum/Plasma) EUDAMED
- Device Name
- COVID-19 IgG/IgM FIA Test (Serum/Plasma) EUDAMED
- Model / Reference
- COV Ab-3012F EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-697424646COVAB001FL8RB EUDAMED
- Basic UDI-DI
- B-697424646COVAB001FL8RB EUDAMED
- EMDN Code
- W0105090501 CORONAVIRUS ANTIGEN (AG) - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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 IgG/IgM FIA Test (Serum/Plasma) by Safecare 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-697424646COVAB001FL8RB | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Safecare Biotech (hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000019109
- Authorised Representative
- UnicareQ GmbH DE-AR-000051497
Sources (1)
- EUDAMED 3c370deb-4a11-4d9e-b670-5a1bd1581bcc 61 fields · synced Oct 6, 2026