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Free Human Chorionic Gonadotropin β Subunit（Free-β-HCG）Detection Kit（Magnetic S…
EUDAMEDClass IVD General (EU MDR)
Ref 200 Tests/kit（DR1123-3）Model 200 Tests/kitRef 100 Tests/kit（DR1123-2）Model 100 Tests/kitRef 200 Tests/kit（DR1022-3）Ref 50 Tests/kit（DR1022-1）Model 50 Tests/kit
Identity
- Trade Name
- Free Human Chorionic Gonadotropin β Subunit（Free-β-HCG）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay) EUDAMEDHuman Chorionic Gonadotropin β（β-HCG）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Device Name
- Free Human Chorionic Gonadotropin β Subunit（Free-β-HCG）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay) EUDAMEDHuman Chorionic Gonadotropin β（β-HCG）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Model / Reference
- 200 Tests/kit EUDAMED200 Tests/kit（DR1123-3） EUDAMED100 Tests/kit EUDAMED100 Tests/kit（DR1123-2） EUDAMED200 Tests/kit（DR1022-3） EUDAMED50 Tests/kit EUDAMED50 Tests/kit（DR1022-1） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969982636 EUDAMED06974969982063 EUDAMED06974969982186 EUDAMED06974969981042 EUDAMED
- Basic UDI-DI
- B-06974969982636 EUDAMEDB-06974969982063 EUDAMEDB-06974969982186 EUDAMEDB-06974969981042 EUDAMED
- EMDN Code
- W0102050213 FREE BETA HCG (PRENATAL SCREENING) EUDAMEDW0102050206 B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT) 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
Free Human Chorionic Gonadotropin β Subunit（Free-β-HCG）Detection Kit（Magnetic S… 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-06974969982636 | 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 (4)
- EUDAMED 242f3e92-a678-4e74-951c-e6da610f2ff3 61 fields · synced Oct 6, 2026
- EUDAMED cd4fab74-127d-423d-a7e7-9a7fcde4bc17 61 fields · synced May 17, 2026
- EUDAMED 3f4e2981-bfd5-4ccd-89dd-f800b488653d 61 fields · synced Jun 20, 2026
- EUDAMED cedc85d5-0c9e-49d4-83cd-a62308fb0c7c 61 fields · synced Jul 23, 2026