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COVID-19 and Influenza A/B Antigen Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref 303050
Identity
- Device Name
- COVID-19 and Influenza A/B Antigen Test Kit EUDAMED
- Model / Reference
- 303050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972412612031 EUDAMED
- Basic UDI-DI
- B-06972412612031 EUDAMED
- EMDN Code
- W010106020301 URINE SEDIMENT TEST KIT (MANUAL) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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 and Influenza A/B Antigen Test Kit by Hangzhou Laihe Biotech 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-06972412612031 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Laihe Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000033566
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 3309714e-3797-4699-8257-1e2158d5e4f7 61 fields · synced Aug 4, 2026