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Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

by Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ 325 variants

Ref E.70549-02004

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-8680941527341AK Basic UDI-DI D-8680941527341AKUDI-DIDate18 May 2022RegisteredStatusActive

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  • Withdrawn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
TOTAL KNEE PROSTHESIS TIBIAL INSERT (C/R) HYPERFLEX 60 / 15 mm (UHMWPE)
Model / Reference
E.70549-02004
Primary DI / UDI-DI
D-8680941527341AK
Basic UDI-DI
B-8680941527341AK
EMDN Code
P0909030101 Bicompartmental primary implant cemented femoral components
Device Class
Class III
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000016470

Other devices from Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from Gold Ortopedi̇ 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