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Alpha-Fetoprotein Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2002E-50
Identity
- Device Name
- Alpha-Fetoprotein Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2002E-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792736351 EUDAMED
- Basic UDI-DI
- B-06955792736351 EUDAMED
- EMDN Code
- W0102039001 ALPHAFETOPROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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 Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — 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-06955792736351 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 9acf2698-147e-4c95-b89b-7bf049a1051b 61 fields · synced Jul 8, 2026
- EUDAMED 00dd4ea8-d4f8-4b85-afd7-9614a20496fd 61 fields · synced Jun 18, 2026