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Odi̇o-Tek

by Gülçi̇n Eren Odi̇o Tek Şi̇şli̇ Şubesi̇ Türkiye EUDAMED

Ref D-SW

EMDN Z12149002

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8699383830032JC Basic UDI-DIDate15 May 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Operator Room Single Walled Patient Room Single Walled Metal Audiological Cabinet
Model / Reference
D-SW
Primary DI / UDI-DI
08699383830032
Basic UDI-DI
8699383830032JC
EMDN Code
Z12149002 Audiometric chambers
Device Class
Class I
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000041962

Other devices from Gülçi̇n Eren Odi̇o Tek Şi̇şli̇ Şubesi̇

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED e1c9d71d-33ad-4d79-8024-fece53847542 61 fields · synced 24 Oct 2026