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Heated humidified high flow nasal cannula oxygen therapy device(HFNC)

by Micomme Medical Technology Development Co., Ltd. EUDAMED

Active European Union

Ref /Model OH-80K

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69593527OH-80KQA Basic UDI-DIDate22 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
OH-80K, /
Primary DI / UDI-DI
06959352701698
Basic UDI-DI
69593527OH-80KQA
EMDN Code
R060202 Oxygen administration humidification systems
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000008694
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Measuring Function

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No