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Heparin Binding Protein Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2025E-75Ref S2025E-100
Identity
- Device Name
- Heparin Binding Protein Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2025E-75 EUDAMEDS2025E-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792737747 EUDAMED06955792737754 EUDAMED
- Basic UDI-DI
- B-06955792737747 EUDAMEDB-06955792737754 EUDAMED
- EMDN Code
- W0102019099 SPECIFIC PROTEINS - OTHER 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
Heparin Binding Protein Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06955792737747 | 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 (2)
- EUDAMED 890ccf94-91b8-413d-9d99-6ba68f11b693 61 fields · synced Jul 30, 2026
- EUDAMED 630f966d-1f3b-4d1d-a7ee-7f813328b187 61 fields · synced May 17, 2026