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Ortopro

by Ortopro Tib. Aletler San. Ve Ti̇c. A.Ş. Esb Şubesi̇ 29 variants

Ref 12.0237

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-08698850185514 Basic UDI-DI 08698850185514UDI-DIDate30 Nov 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  • Withdrawn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
Ancale Tibial Component Cemented Size 2
Model / Reference
12.0237
Primary DI / UDI-DI
08698850185514
Basic UDI-DI
B-08698850185514
EMDN Code
P090903020104 Bicompartmental primary implant cemented fixed bearing tibial plates
Device Class
Class III
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000015164

Other devices from Ortopro Tib. Aletler San. Ve Ti̇c. A.Ş. Esb Şubesi̇

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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