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Alpha-Fetoprotein (AFP) Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 100 tests/kit
Identity
- Device Name
- Alpha-Fetoprotein (AFP) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 100 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937287300643 EUDAMED
- Basic UDI-DI
- B-06937287300643 EUDAMED
- EMDN Code
- W0102039001 ALPHAFETOPROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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) Assay Kit (Chemiluminescent Immunoassay) by Shenzhen AmTech Bioengineering Ltd., Inc. — 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-06937287300643 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen AmTech Bioengineering Ltd., Inc.
- EUDAMED SRN
- CN-MF-000043067
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 84951b89-b357-43e0-bead-92ea43b09a04 61 fields · synced Jun 19, 2026