Skip to content

TST External Fixator System

by Tst Rakor Ve Tibbi̇ Aletler San.ve Ti̇c.ltd.şti̇. EUDAMED

Active European Union

Ref 41085000120Model OWOFIX DISTRACTOR

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08680858412228 Basic UDI-DIDate16 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Owo-Fix Distractor Proximal Arc - R 120°
Model / Reference
OWOFIX DISTRACTOR, 41085000120
Primary DI / UDI-DI
08680858412228
Basic UDI-DI
B-08680858412228
EMDN Code
P09120403 Osteosynthesis distractors
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000017767

Other devices from Tst Rakor Ve Tibbi̇ Aletler San.ve Ti̇c.ltd.şti̇.

See all devices from Tst Rakor Ve Tibbi̇ Aletler San.ve Ti̇c.ltd.şti̇. →

Properties

  • Implantable

Other properties (12)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No