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Ortoknee

by Ortonom Medi̇kal Ürünleri̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ 109 variants

Ref DZ00109Model UHMW POLYETHYLENE ROTATION Insert (PS)

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08682076500633 Basic UDI-DIDate18 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  • Withdrawn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
OrtoKnee UHMW POLYETHYLENE ROTATION Insert (PS) Size 2 /16mm
Model / Reference
UHMW POLYETHYLENE ROTATION Insert (PS), DZ00109
Primary DI / UDI-DI
08682076500633
Basic UDI-DI
B-08682076500633
EMDN Code
P090903020201 Bicompartmental primary implant mobile bearing tibial inserts
Device Class
Class III
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000026671

Other devices from Ortonom Medi̇kal Ürünleri̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from Ortonom Medi̇kal Ürünleri̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →

Properties

  • Sterile
  • Implantable

Other properties (9)

  • 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