Skip to content

Medical PSA Oxygen Generator System

by Tesa Medi̇kal Sağlik Hi̇zmetleri̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ Türkiye EUDAMED

Ref OXYVITAL OM-40 EMDN R060202

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08699433306050 Basic UDI-DIDate22 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
OXYVITAL OM-40
Primary DI / UDI-DI
08699433306050
Basic UDI-DI
B-08699433306050
EMDN Code
R060202 Oxygen administration humidification systems
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000020519

Other devices from Tesa Medi̇kal Sağlik Hi̇zmetleri̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from Tesa Medi̇kal Sağlik Hi̇zmetleri̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →

Properties & raw data

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

Sources (1)

  • EUDAMED 4c50aa16-39c4-4807-89fd-be1a58239fc5 61 fields · synced 24 Oct 2026