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Human Epididymis Protein 4（HE4）Detection Kit（Magnetic Solid Phase Chemiluminesc…
EUDAMEDClass IVD General (EU MDR)
Ref 200 Tests/kit（DR1098-3）Model 200 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
- 200 Tests/kit EUDAMED200 Tests/kit（DR1098-3） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969982520 EUDAMED
- Basic UDI-DI
- B-06974969982520 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-06974969982520 | 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 34b83ae6-bf4a-4379-afc8-b52884aec818 61 fields · synced Jul 21, 2026