← Back to catalogue
VivaDiag Heart Fatty Acid Binding Protein Control Solution (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref VIC13-03-011Model VIC13
Identity
- Trade Name
- VivaDiag Heart Fatty Acid Binding Protein Control Solution (FIA) EUDAMED
- Device Name
- VivaDiag Heart Fatty Acid Binding Protein Control Solution (FIA) EUDAMED
- Model / Reference
- VIC13 EUDAMEDVIC13-03-011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VIC132K EUDAMED
- Basic UDI-DI
- B-VIC132K 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
VivaDiag Heart Fatty Acid Binding Protein 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-VIC132K | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012160
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 04787375-6724-41b9-838e-7e5318832980 61 fields · synced Jun 18, 2026