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High Sensitivity Cardiac Troponin I Control Solution (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref VIC113-03-011Model VIC113
Identity
- Trade Name
- High Sensitivity Cardiac Troponin I Control Solution (FIA) EUDAMED
- Device Name
- High Sensitivity Cardiac Troponin I Control Solution (FIA) EUDAMED
- Model / Reference
- VIC113 EUDAMEDVIC113-03-011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937339209108 EUDAMED
- Basic UDI-DI
- B-06937339209108 EUDAMED
- EMDN Code
- W0102152004 CARDIAC MARKER CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
High Sensitivity Cardiac Troponin I Control Solution (FIA) by VivaChek Biotech (Hangzhou) 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-06937339209108 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012160
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 9df24569-2bdc-4e30-8386-d28480a2e06e 61 fields · synced Jul 13, 2026