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Alpha Fetoprotein (AFP) Detection Kit （Magnetic Solid Phase Chemiluminescent Im…
EUDAMEDClass IVD General (EU MDR)
Ref 100 Tests/kit（DR1016-2）Model 100 Tests/kit
Identity
- Trade Name
- Alpha Fetoprotein (AFP) Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Device Name
- Alpha Fetoprotein (AFP) Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Model / Reference
- 100 Tests/kit EUDAMED100 Tests/kit（DR1016-2） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969980069 EUDAMED
- Basic UDI-DI
- B-06974969980069 EUDAMED
- EMDN Code
- W0102039001 ALPHAFETOPROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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) Detection Kit （Magnetic Solid Phase Chemiluminescent Im… by Biobase Diagnostic Technology (Shandong) Co., Ltd. — Class IVD General…
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-06974969980069 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Diagnostic Technology (Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025964
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED a176f2cb-b881-4744-b52d-fa7b9bc548e9 61 fields · synced Jul 19, 2026