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Creatine kinase
EUDAMEDClass IVD General (EU MDR)
Ref Ck-Mk-0520Model Creatine kinase
by Ns Biotec
Identity
- Trade Name
- Creatine kinase EUDAMED
- Device Name
- Creatine kinase EUDAMED
- Model / Reference
- Creatine kinase EUDAMEDCk-Mk-0520 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CreatineKinase-VC EUDAMED
- Basic UDI-DI
- B-CreatineKinase-VC EUDAMED
- EMDN Code
- W01010113 CREATINE KINASE - TOTAL EUDAMED
Classification
- Device Class
- Class IVD General 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
Creatine kinase by Ns Biotec — 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-CreatineKinase-VC | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ns Biotec
- EUDAMED SRN
- EG-MF-000032515
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 1a337102-ec08-4adf-a207-4e0c442868b7 61 fields · synced Jul 18, 2026