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CREATINE KINASE Kit

EUDAMED

Class IVD General (EU MDR)

Ref B28096Model CREATINE KINASE Kit 208mLRef B28120Model CREATININE Kit 312mLRef B28097Model CREATINE KINASE Kit 78mL

by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇

Identity

Trade Name
CREATINE KINASE Kit EUDAMED
CREATININE Kit EUDAMED
Device Name
CREATINE KINASE Kit EUDAMED
CREATININE Kit EUDAMED
Model / Reference
CREATINE KINASE Kit 208mL EUDAMED
B28096 EUDAMED
CREATININE Kit 312mL EUDAMED
B28120 EUDAMED
CREATINE KINASE Kit 78mL EUDAMED
B28097 EUDAMED

Identifiers

Primary DI / UDI-DI
08683555618702 EUDAMED
08683555618771 EUDAMED
08683555618719 EUDAMED
Basic UDI-DI
B-08683555618702 EUDAMED
B-08683555618771 EUDAMED
B-08683555618719 EUDAMED
EMDN Code
W01010113 CREATINE KINASE - TOTAL EUDAMED
W01010207 CREATININE 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 Kit 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 (3)

  • EUDAMED b187f437-3d8d-43ef-b5a7-36604444d56e 61 fields · synced Jul 24, 2026
  • EUDAMED 0c9b4c0a-5d14-462a-a2a1-932fd733dea2 61 fields · synced May 18, 2026
  • EUDAMED 9817e0a4-1416-4596-a021-3f5dbe26ca20 61 fields · synced May 18, 2026