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Key for UNI-Smile and Smile 3

by Titamed EUDAMED

Active European Union

Ref IT0314Model Distractor Keys

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number54040243BASIC0075H Basic UDI-DIDate8 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
Distractor Keys, IT0314
Primary DI / UDI-DI
05404024307858
Basic UDI-DI
54040243BASIC0075H
EMDN Code
L098002 Orthopaedic instruments keys, reusable
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000110

Other devices from Titamed

See all devices from Titamed →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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