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4 in 1 Guide - LNK

by Orthokey Italia SRL

Ref GS.N0120Model ORTHOKEY Surgical instruments IR

Active European Union

CE MDR

Valid until

16 Dec 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BUREAU VERITAS ITALIA S.P.A.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805267596SurgicalInstrD9 Basic UDI-DI 08052675960723UDI-DIDate24 Mar 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
ORTHOKEY Surgical instruments IR, GS.N0120
Primary DI / UDI-DI
08052675960723
Basic UDI-DI
805267596SurgicalInstrD9
Direct Marketing DI
08052675960723
EMDN Code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000026488

Other devices from Orthokey Italia SRL

See all devices from Orthokey Italia SRL →

Properties

  • Reusable
  • Reprocessed

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No