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BILIRUBIN DIRECT Kit

EUDAMED

Class IVD General (EU MDR)

Ref B34055Model BILIRUBIN DIRECT Kit 183mL

by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇

Identity

Trade Name
BILIRUBIN DIRECT Kit EUDAMED
Device Name
BILIRUBIN DIRECT Kit EUDAMED
Model / Reference
BILIRUBIN DIRECT Kit 183mL EUDAMED
B34055 EUDAMED

Identifiers

Primary DI / UDI-DI
08683555616432 EUDAMED
Basic UDI-DI
B-08683555616432 EUDAMED
EMDN Code
W01010203 BILIRUBIN 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

BILIRUBIN DIRECT 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 (1)

  • EUDAMED 6eda9bce-b698-411f-a809-8fa8a293caa5 61 fields · synced Jun 19, 2026