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Human Epididymal Protein 4 (HE4)Assay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 69543760F000486MModel 100 Tests
Identity
- Trade Name
- Human Epididymal Protein 4 (HE4)Assay Kit EUDAMED
- Device Name
- Human Epididymal Protein 4 (HE4)Assay Kit EUDAMED
- Model / Reference
- 100 Tests EUDAMED69543760F000486M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954376005319 EUDAMED
- Basic UDI-DI
- B-06954376005319 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
Yes
EUDAMED
Microbial Substances
Yes
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 Epididymal Protein 4 (HE4)Assay Kit by Beijing Leadman Biochemistry Co., Ltd. — 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-06954376005319 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Leadman Biochemistry Co., Ltd.
- EUDAMED SRN
- CN-MF-000020150
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED e02b9b29-06c6-4d65-9b47-d5d4547a0bb3 61 fields · synced Oct 6, 2026