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Karaoğlu

EUDAMED

Class I (EU MDR)

Ref KR161.08Model KARAOĞLU

by Karaoğlu Baskül Ve Cerrahi̇ Aletler İmal. San. Ti̇c. Ltd. Şti̇

Identity

Trade Name
KARAOĞLU EUDAMED
Device Name
REUSABLE SURGICAL HAND INSTRUMENTS EUDAMED
Model / Reference
KARAOĞLU EUDAMED
KR161.08 EUDAMED

Identifiers

Primary DI / UDI-DI
08699041054206 EUDAMED
Basic UDI-DI
8699041KARAOGLU2004QU EUDAMED
EMDN Code
L059001 VAGINAL SPECULUMS, REUSABLE EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Vaginal speculum, reusable

Karaoğlu by Karaoğlu Baskül Ve Cerrahi̇ Aletler İmal. San. Ti̇c. Ltd. Şti̇ — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Vaginal speculum, reusable.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
TR-MF-000041867

Sources (1)

  • EUDAMED 3585dcbf-488f-44a2-9d0a-340a955dde18 61 fields · synced Jul 10, 2026