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Orti̇mplant

by Ortimplant Ortopedi ve Tıbbi Aletleri Sanayi Ticaret Limited Şirketi 1,000+ variants

Ref O1115238114

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08683206677058 Basic UDI-DI 08683206677058UDI-DIDate6 May 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Lateral Distal Humerus Kilitli Plak 2 Titanyum 14 Delik Sol (Lateral Distal Humerus Locking Plate 2 Titanium 14 Holes Left)
Model / Reference
O1115238114
Primary DI / UDI-DI
08683206677058
Basic UDI-DI
B-08683206677058
EMDN Code
P09120501 Osteosynthesis compression plates
Device Class
Class IIb
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
TR-MF-000017438

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Properties

  • 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