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Cardiac Combo (cTnI/CK-MB) Control Solution (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref VIC45-03-011Model VIC45
Identity
- Trade Name
- Cardiac Combo (cTnI/CK-MB) Control Solution (FIA) EUDAMED
- Device Name
- Cardiac Combo (cTnI/CK-MB) Control Solution (FIA) EUDAMED
- Model / Reference
- VIC45 EUDAMEDVIC45-03-011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VIC452Y EUDAMED06937339210616 EUDAMED
- Basic UDI-DI
- B-VIC452Y EUDAMEDB-06937339210616 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
Yes
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Cardiac Combo (cTnI/CK-MB) 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-VIC452Y | Class IVD General | Active |
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Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012160
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 6e794db7-1aa8-489b-b676-47acf0db307a 61 fields · synced Oct 6, 2026
- EUDAMED b888c4cc-110d-486d-b869-9e6476cd1950 61 fields · synced Jul 18, 2026