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High-sensitive cardiac troponin I Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref S2076E-24Ref S2154E-200Ref S2076E-48Ref 100 testsModel 25 tests，50 tests，2×50 tests，100 tests，2×100 testsRef 2×50 test
Identity
- Trade Name
- High Sensitive Cardiac Troponin I Assay kit(Chemiluminescence Immunoassay Method） EUDAMED
- Device Name
- High-sensitive cardiac troponin I Assay Kit (Chemiluminescent Immunoassay) EUDAMEDTroponin I Chemiluminescence Immunoassay Kit EUDAMEDHigh Sensitive Cardiac Troponin I Assay kit(Chemiluminescence Immunoassay Method） EUDAMED
- Model / Reference
- S2076E-24 EUDAMEDS2154E-200 EUDAMEDS2076E-48 EUDAMED25 tests，50 tests，2×50 tests，100 tests，2×100 tests EUDAMED100 tests EUDAMED2×50 test EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792737921 EUDAMED06955792743076 EUDAMED06955792737938 EUDAMED06978465237054 EUDAMED06978465232202 EUDAMED
- Basic UDI-DI
- B-06955792737921 EUDAMEDB-06955792743076 EUDAMEDB-06955792737938 EUDAMED697846523ProteinC10RE EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- France EUDAMEDAustria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
High-sensitive cardiac troponin I Assay Kit (Chemiluminescent Immunoassay) by Sansure Biotech Inc. — Class IVD General — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06955792737921 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06955792737921 | 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 e94cf04e-5abf-4780-b2cd-811c7a713664 61 fields · synced Sep 17, 2026
- EUDAMED c6c36b0c-4443-433c-accc-f41cba1b1b60 61 fields · synced May 17, 2026
- EUDAMED 77aa0cde-7e5a-436e-b931-630e02aded7f 61 fields · synced May 18, 2026
- EUDAMED feeb15ce-ea59-4187-999e-a5a0db853cd6 61 fields · synced Jul 10, 2026
- EUDAMED 984718e2-fe5a-4b23-a27c-e5695a2a5577 61 fields · synced Jul 11, 2026