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Hyperbaric Oxygen Treatment System

by Yaklaşim Maki̇na Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ Türkiye EUDAMED

Ref Omega, CORAL, TRCO2

EMDN Z120308

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08682276686014 Basic UDI-DIDate31 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Hyperbaric Oxygen Treatment System
Model / Reference
Omega, CORAL, TRCO2
Primary DI / UDI-DI
08682276686014, 08682276686038, 08682276686045
Basic UDI-DI
B-08682276686014, B-08682276686038, B-08682276686045
EMDN Code
Z120308 Hyperbaric chambers
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000029488

Other devices from Yaklaşim Maki̇na Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

Properties & raw data

Show properties, registry sources and raw records
  • Administering Medicine YesEUDAMEDNoEUDAMED
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (3)

  • EUDAMED 65720b47-46cb-43f6-8df8-1755328f73f6 61 fields · synced 22 Oct 2026
  • EUDAMED 08682276686038|B-08682276686038 61 fields · synced 17 May 2026
  • EUDAMED 08682276686045|B-08682276686045 61 fields · synced 19 May 2026