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Oltho

by Seles Saglik Hizmetleri Imalat Oto Kir.ins.san.tic.a.s. Türkiye EUDAMED

Ref N00135Model Proximal Femoral Nail System PFN End cap I

EMDN P09120604

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08682431310464 Basic UDI-DIDate14 May 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 23 Oct 2026

Device Name
Oltho Proximal Femur Nail Top Screw For Blade 15mm
Model / Reference
Proximal Femoral Nail System PFN End cap I, N00135
Primary DI / UDI-DI
08682431310464
Basic UDI-DI
B-08682431310464
EMDN Code
P09120604 Osteosynthesis nail-screw systems
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000015943

Other devices from Seles Saglik Hizmetleri Imalat Oto Kir.ins.san.tic.a.s.

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Properties & raw data

Show properties, registry sources and raw records
  • Implantable
Other properties (10)
  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 1f3c0021-0b25-4719-ab66-a4a74e6e9272 61 fields · synced 23 Oct 2026