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Oltho

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

Ref HCS00085Model HEADLESS COMPRESSION SCREW

EMDN P09120503

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08682431315308 Basic UDI-DIDate19 Oct 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 24 Oct 2026

Device Name
Oltho Headless Compression Screw 5.0mm x 55mm
Model / Reference
HEADLESS COMPRESSION SCREW, HCS00085
Primary DI / UDI-DI
08682431315308
Basic UDI-DI
B-08682431315308
EMDN Code
P09120503 Osteosynthesis screw-plate 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 08682431315308|B-08682431315308 61 fields · synced 24 Oct 2026