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cTnI Rapid Quantitative Test
EUDAMEDClass IVD General (EU MDR)
Ref 0842Model 25 servings/boxModel 20 boxes/carton
Identity
- Trade Name
- cTnI Rapid Quantitative Test EUDAMED
- Device Name
- cTnI Rapid Quantitative Test EUDAMED
- Model / Reference
- 25 servings/box EUDAMED0842 EUDAMED20 boxes/carton EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977565580848 EUDAMED16977565580845 EUDAMED
- Basic UDI-DI
- B-06977565580848 EUDAMEDB-16977565580845 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
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
cTnI Rapid Quantitative Test by Coei Biotech Co.Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06977565580848 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Coei Biotech Co.Ltd.
- EUDAMED SRN
- CN-MF-000049509
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 288a2667-c95a-4e0c-9896-22b7d96d3c6b 61 fields · synced Jul 29, 2026
- EUDAMED 046c2db0-e94c-439e-a79f-2af645b782c1 61 fields · synced Jul 29, 2026