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High-sensitivity Cardiac Troponin I Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2141E-25Ref S2141E-150Ref S2141E-100Ref S2141E-200Ref S2141E-75
Identity
- Device Name
- High-sensitivity Cardiac Troponin I Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2141E-25 EUDAMEDS2141E-150 EUDAMEDS2141E-100 EUDAMEDS2141E-200 EUDAMEDS2141E-75 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792742260 EUDAMED06955792742307 EUDAMED06955792742291 EUDAMED06955792742314 EUDAMED06955792742284 EUDAMED
- Basic UDI-DI
- B-06955792742260 EUDAMEDB-06955792742307 EUDAMEDB-06955792742291 EUDAMEDB-06955792742314 EUDAMEDB-06955792742284 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 I 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-06955792742260 | 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 (5)
- EUDAMED bc0a2e5a-c7e8-4d3e-93e5-45fc47b2a637 61 fields · synced Jul 26, 2026
- EUDAMED ffa8dd65-115b-4c36-a70b-8e57d1bd6c6a 61 fields · synced May 19, 2026
- EUDAMED 37e59c96-8d1a-4b3e-9d66-5cdfe1bdb42e 61 fields · synced May 19, 2026
- EUDAMED 303d1ead-5332-4ae6-bb08-c4afb5780896 61 fields · synced May 19, 2026
- EUDAMED e1bd07df-7ed1-44da-9749-6be9dbf83c8c 61 fields · synced May 19, 2026