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Cardiac Troponin (cTnI) Assay Kits (Lateral Flow Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 745005Model 25 Tests/Kit
Identity
- Trade Name
- Cardiac Troponin (cTnI) Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Device Name
- Cardiac Troponin (cTnI) Assay Kits (Lateral Flow Immunoassay) EUDAMED
- Model / Reference
- 25 Tests/Kit EUDAMED745005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139075784 EUDAMED
- Basic UDI-DI
- B-06978139075784 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T EUDAMED
Classification
- Device Class
- Class 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
Cardiac Troponin (cTnI) Assay Kits (Lateral Flow Immunoassay) by Shenzhen Lifotronic Technology Co., Ltd. — 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-06978139075784 | Class IVD General | 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 (1)
- EUDAMED a285674b-0ca3-42a7-a87a-9e016d36209b 61 fields · synced Jun 19, 2026