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HE4 Human Epididymal Protein 4 (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref HE4706-AE10Y, HE4706-AE10N, HE4706-AE20Y, HE4706-AE20N
Identity
- Trade Name
- HE4 Human Epididymal Protein 4 (CLIA) EUDAMED
- Device Name
- HE4 Human Epididymal Protein 4 (CLIA) EUDAMED
- Model / Reference
- HE4706-AE10Y, HE4706-AE10N, HE4706-AE20Y, HE4706-AE20N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-HE4706-AEFT EUDAMED
- Basic UDI-DI
- B-HE4706-AEFT EUDAMED
- EMDN Code
- W0102030119 HUMAN EPIDIDYMIS PROTEIN 4 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
HE4 Human Epididymal Protein 4 (CLIA) by Hangzhou Aichek Medical Technology 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-HE4706-AEFT | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 22beb565-eb8d-478c-b6e3-7926e48efdb6 61 fields · synced Jun 18, 2026
- EUDAMED 22beb565-eb8d-478c-b6e3-7926e48efdb6-1 61 fields · synced Jun 9, 2026