← Back to catalogue
Creatine Kinase-MB Test Kit (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref VID10-03-011Model VID10
Identity
- Trade Name
- Creatine Kinase-MB Test Kit (FIA) EUDAMED
- Device Name
- Creatine Kinase-MB Test Kit (FIA) EUDAMED
- Model / Reference
- VID10 EUDAMEDVID10-03-011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VID102J EUDAMED
- Basic UDI-DI
- B-VID102J EUDAMED
- EMDN Code
- W0102160701 CREATINE KINASE - MB MASS - 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
Creatine Kinase-MB Test Kit (FIA) by VivaChek Biotech (Hangzhou) 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-VID102J | 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 74c953ab-1f48-467e-a16d-3306a478c3ff 61 fields · synced Oct 6, 2026