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Hikoneb Oxybreath 10L

by KARE MEDiKAL VE ANALiTiK CiH. SAN. VE TiC. LTD. STi. Türkiye EUDAMED

Ref M000021Model Hikoneb Oxybreath 10L EMDN Z12159004

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08698934521559 Basic UDI-DIDate28 Apr 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  • Withdrawn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 22 Oct 2026

Device Name
Oxygen Concentrator
Model / Reference
Hikoneb Oxybreath 10L, M000021
Primary DI / UDI-DI
08698934521559
Basic UDI-DI
B-08698934521559
EMDN Code
Z12159004 Oxygen concentrators
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000020956

Other devices from KARE MEDiKAL VE ANALiTiK CiH. SAN. VE TiC. LTD. STi.

See all devices from KARE MEDiKAL VE ANALiTiK CiH. SAN. VE TiC. LTD. STi. →

Properties & raw data

Show properties, registry sources and raw records
  • Incorporates Medicinal Product
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
  • Measuring Function: No

Sources (1)

  • EUDAMED 47653ce6-a9b4-456d-bb6d-95bd9452859d 61 fields · synced 22 Oct 2026