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Medical Oxygen Production and Storage System

by Özcan Kardeşler Tip Ci̇hazlari Sanayi̇ Ve Ti̇caret Ltd. Şti̇. 23 variants

Ref AO-353E

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08699050400377 Basic UDI-DI 08699050400377UDI-DIDate6 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Medical Oxygen Production and Storage System
Model / Reference
AO-353E
Primary DI / UDI-DI
08699050400377
Basic UDI-DI
B-08699050400377
EMDN Code
Z12159004 Oxygen concentrators
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000020144

Other devices from Özcan Kardeşler Tip Ci̇hazlari Sanayi̇ Ve Ti̇caret Ltd. Şti̇.

See all devices from Özcan Kardeşler Tip Ci̇hazlari Sanayi̇ Ve Ti̇caret Ltd. Şti̇. →

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No