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Cardiac Combo (cTnI/CK-MB/MY0) Test Kit (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref VID15-03-011Model VID15
Identity
- Trade Name
- Cardiac Combo (cTnI/CK-MB/MY0) Test Kit (FIA) EUDAMED
- Device Name
- Cardiac Combo (cTnI/CK-MB/MY0) Test Kit (FIA) EUDAMED
- Model / Reference
- VID15 EUDAMEDVID15-03-011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VID152U EUDAMED
- Basic UDI-DI
- B-VID152U EUDAMED
- EMDN Code
- W0102160706 MULTIPLE CARDIAC MARKERS - RT & POC 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
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
Cardiac Combo (cTnI/CK-MB/MY0) Test Kit (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-VID152U | 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 (1)
- EUDAMED 20ef56a4-01e5-4852-98ec-a765054b6dae 61 fields · synced Oct 5, 2026