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TST External Fixator System

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

Ref 41086000120Model OWOFIX DISTRACTOR

EMDN P09120403

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08680858412235 Basic UDI-DIDate16 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Owo-Fix Distractor Proximal Arc - L 120°
Model / Reference
OWOFIX DISTRACTOR, 41086000120
Primary DI / UDI-DI
08680858412235
Basic UDI-DI
B-08680858412235
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 08680858412235|B-08680858412235 61 fields · synced 25 Oct 2026