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Hikoneb Oxybreath Mini 3

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

Ref M000346Model Hikoneb Oxybreath Mini 3 EMDN Z12159004

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08698934521481 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  • Withdrawn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 Mini 3, M000346
Primary DI / UDI-DI
08698934521481
Basic UDI-DI
B-08698934521481
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
  • Administering Medicine
  • Incorporates Medicinal Product
Other properties (9)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No

Sources (1)

  • EUDAMED 99243eed-ad66-4e23-b6f9-ba8b3b674cd2 61 fields · synced 22 Oct 2026