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High-Sensitivity Troponin T STAT (hs-cTnT STAT) eCLIA
EUDAMEDClass C (EU MDR)
Ref 691031Model 50T, 2×50T, 100T ,2×100TModel 100T
Identity
- Trade Name
- High-Sensitivity Troponin T STAT (hs-cTnT STAT) eCLIA EUDAMED
- Device Name
- High-Sensitivity Troponin T STAT (hs-cTnT STAT) eCLIA EUDAMED
- Model / Reference
- 50T, 2×50T, 100T ,2×100T EUDAMED691031 EUDAMED100T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341689292 EUDAMED
- Basic UDI-DI
- 69703416803205039JN EUDAMEDB-06970341689292 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
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
New Device
No
EUDAMED
High-Sensitivity Troponin T STAT (hs-cTnT STAT) eCLIA by Shenzhen Lifotronic Technology Co., Ltd. — Class C — IVDD, IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69703416803205039JN | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 69703416803205039JN | Class C | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 80f1002d-725a-48ca-8caa-abfec13128bb 61 fields · synced Jul 9, 2026
- EUDAMED 0e7a82e7-6a05-442c-b2e9-af67dd4d85d1 61 fields · synced May 19, 2026