Identity
- Trade Name
- Alpha-Fetoprotein (AFP) Test Kit EUDAMED
- Device Name
- Alpha-Fetoprotein (AFP) Test Kit EUDAMED
- Model / Reference
- M4402CV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315739184 EUDAMED
- Basic UDI-DI
- B-06973315739184 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
Nanjing Vazyme Medical Technology Co., Ltd. offers an Alpha-Fetoprotein (AFP) Test Kit, a reliable device for diagnosing liver cancer and monitoring fetal development. The kit is designed to provide accurate results in clinical settings.
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-06973315739184 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED cce1c34c-e028-4d9b-8a1d-07facc4e29e4 61 fields · synced Oct 7, 2026