Skip to content

Oltho

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

Ref N00004Model Proximal Femoral Nail System PFN Nail (extended) EMDN P09120604

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08682431309154 Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Oltho Proximal Femur Nail (Long) 360mm x 9mm Left
Model / Reference
Proximal Femoral Nail System PFN Nail (extended), N00004
Primary DI / UDI-DI
08682431309154
Basic UDI-DI
B-08682431309154
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.

See all devices from Seles Saglik Hizmetleri Imalat Oto Kir.ins.san.tic.a.s. →

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 08682431309154|B-08682431309154 61 fields · synced 25 Oct 2026