Identity
- Trade Name
- Alpha-Fetoprotein (AFP) Test Kit EUDAMED
- Device Name
- Alpha-Fetoprotein (AFP) Test Kit EUDAMED
- Model / Reference
- M4403CC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979469761323 EUDAMED
- Basic UDI-DI
- B-06979469761323 EUDAMED
- EMDN Code
- W0102039001 ALPHAFETOPROTEIN 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
Alpha-Fetoprotein (AFP) Test Kit by Nanjing Vazyme Medical Technology Co., Ltd. — Class IVD General — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06979469761323 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED cd9d3b70-9f53-48cc-a781-4bb50343dea4 61 fields · synced Oct 7, 2026