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Creatine Kinase (CK-NAC)

EUDAMED

Class IVD General (EU MDR)

Ref B21096Model Creatine Kinase 213 mL

by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇

Identity

Trade Name
Creatine Kinase (CK-NAC) EUDAMED
Device Name
Creatine Kinase EUDAMED
Model / Reference
Creatine Kinase 213 mL EUDAMED
B21096 EUDAMED

Identifiers

Primary DI / UDI-DI
08683555610317 EUDAMED
Basic UDI-DI
B-08683555610317 EUDAMED
EMDN Code
W01010113 CREATINE KINASE - TOTAL EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Türkiye 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 (CK-NAC) by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ — 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

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Manufacturer

Manufacturer
Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
EUDAMED SRN
TR-MF-000040334

Sources (1)

  • EUDAMED 5e3faa73-c3ca-44ad-850a-aa8b3f98eceb 61 fields · synced Oct 7, 2026