← Back to catalogue

Creatine Kinase-MB (CK-MB)

EUDAMED

Class IVD General (EU MDR)

Ref B21093Model Creatine Kinase-MB 216 mL

by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇

Identity

Trade Name
Creatine Kinase-MB (CK-MB) EUDAMED
Device Name
Creatine Kinase-MB EUDAMED
Model / Reference
Creatine Kinase-MB 216 mL EUDAMED
B21093 EUDAMED

Identifiers

Primary DI / UDI-DI
08683555601032 EUDAMED
Basic UDI-DI
B-08683555601032 EUDAMED
EMDN Code
W01010114 CREATINE KINASE - MB ACTIVITY (CC) 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-MB (CK-MB) 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (1)

  • EUDAMED 7572d20a-12ee-4cbc-9c0a-8d00b95d9f15 61 fields · synced Jun 19, 2026