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SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit
EUDAMEDClass IVD General (EU MDR)
Ref IS-MY-010-50Model 50 tests/kit
Identity
- Trade Name
- SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit EUDAMED
- Device Name
- SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit EUDAMED
- Model / Reference
- 50 tests/kit EUDAMEDIS-MY-010-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974677691714 EUDAMED
- Basic UDI-DI
- B-06974677691714 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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 /Influenza A/B virus antigen Rapid Test kit by Shanghai BioGerm Medical Technology 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-06974677691714 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shanghai BioGerm Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018164
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 4a970d04-42f2-4f64-b7d0-2a74e0d6af51 61 fields · synced Jun 11, 2026