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Human Epididymis Protein 4 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2028E-50Ref S2028E-200Ref S2028E-150Ref S2028E-75
Identity
- Device Name
- Human Epididymis Protein 4 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2028E-50 EUDAMEDS2028E-200 EUDAMEDS2028E-150 EUDAMEDS2028E-75 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792738515 EUDAMED06955792738553 EUDAMED06955792738546 EUDAMED06955792738522 EUDAMED
- Basic UDI-DI
- B-06955792738515 EUDAMEDB-06955792738553 EUDAMEDB-06955792738546 EUDAMEDB-06955792738522 EUDAMED
- EMDN Code
- W0102030119 HUMAN EPIDIDYMIS PROTEIN 4 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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 Epididymis Protein 4 Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — 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-06955792738515 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED 01927117-8b52-465f-86bb-13460d7679cd 61 fields · synced Oct 6, 2026
- EUDAMED 43c87911-c048-45eb-8244-1498b9ccc09a 61 fields · synced May 18, 2026
- EUDAMED 745db3cc-2593-467e-9082-2c670eaed44a 61 fields · synced May 19, 2026
- EUDAMED ac68ccad-72d5-426f-8772-35bc4acbdac3 61 fields · synced May 19, 2026