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High-sensitivity Cardiac Troponin T Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2026E-25Ref S2026E-200Ref S2026E-150
Identity
- Device Name
- High-sensitivity Cardiac Troponin T Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2026E-25 EUDAMEDS2026E-200 EUDAMEDS2026E-150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792738386 EUDAMED06955792738430 EUDAMED06955792738423 EUDAMED
- Basic UDI-DI
- B-06955792738386 EUDAMEDB-06955792738430 EUDAMEDB-06955792738423 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T 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
High-sensitivity Cardiac Troponin T 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-06955792738386 | 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 (3)
- EUDAMED 4a33f59b-3e3d-424f-b191-734202061861 61 fields · synced Jul 13, 2026
- EUDAMED c0e3a941-e17b-4361-a5fc-95b86bdd2f50 61 fields · synced May 19, 2026
- EUDAMED 0bc8e4c3-014c-448d-be07-16de400325a7 61 fields · synced May 19, 2026