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Heart fatty acid binding protein Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref S2077E-24Ref S2077E-48
Identity
- Device Name
- Heart fatty acid binding protein Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- S2077E-24 EUDAMEDS2077E-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792737945 EUDAMED06955792737952 EUDAMED
- Basic UDI-DI
- B-06955792737945 EUDAMEDB-06955792737952 EUDAMED
- EMDN Code
- W01021302 HEART-TYPE FATTY ACID BINDING PROTEIN 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
Heart fatty acid binding protein Assay Kit (Chemiluminescent Immunoassay) 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-06955792737945 | 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 5f77dd3a-3ef5-4938-a241-e943480903a9 61 fields · synced Oct 6, 2026
- EUDAMED 703e2c2e-870b-469b-82d1-a8a195d5132b 61 fields · synced May 17, 2026