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High-Sensitivity Cardiac Troponin I (hs-cTnI) Test Kit (Immunofluorescence Meth…
EUDAMEDClass IVD General (EU MDR)
Ref W-IF2-cTnI-40Model 40 tests/kit
Identity
- Trade Name
- High-Sensitivity Cardiac Troponin I (hs-cTnI) Test Kit (Immunofluorescence Method) EUDAMED
- Device Name
- High-Sensitivity Cardiac Troponin I (hs-cTnI) Test Kit (Immunofluorescence Method) EUDAMED
- Model / Reference
- 40 tests/kit EUDAMEDW-IF2-cTnI-40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978896415472 EUDAMED
- Basic UDI-DI
- B-06978896415472 EUDAMED
- EMDN Code
- W0102160703 TROPONIN I/T - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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 (hs-cTnI) Test Kit (Immunofluorescence Meth… by Wuhan Easydiagnosis Biomedicine Co., Ltd. — Class IVD General — IVDD…
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-06978896415472 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Easydiagnosis Biomedicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000019908
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED d35cbdbc-4dbf-4068-80ea-b67e1e471119 61 fields · synced Oct 7, 2026