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Human Epididymis Protein 4（HE4）Detection Kit（Magnetic Solid Phase Chemiluminesc…
EUDAMEDClass IVD General (EU MDR)
Ref 50 Tests/kit（DR1098-1）Model 50 Tests/kit
Identity
- Trade Name
- Human Epididymis Protein 4（HE4）Detection Kit（Magnetic Solid Phase Chemiluminescent） EUDAMED
- Device Name
- Human Epididymis Protein 4（HE4）Detection Kit（Magnetic Solid Phase Chemiluminescent） EUDAMED
- Model / Reference
- 50 Tests/kit EUDAMED50 Tests/kit（DR1098-1） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969981387 EUDAMED
- Basic UDI-DI
- B-06974969981387 EUDAMED
- EMDN Code
- W0102030119 HUMAN EPIDIDYMIS PROTEIN 4 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
Human Epididymis Protein 4（HE4）Detection Kit（Magnetic Solid Phase Chemiluminesc… 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-06974969981387 | 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 8a2a8050-6de0-46ef-830e-d13ca77031ad 61 fields · synced Oct 6, 2026