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Oxygen Therapy

by Flexicare Medical Limited EUDAMED

Active European Union

Ref 038-13-115

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05055788713616 Basic UDI-DIDate14 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

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.

Specification

EUDAMED

Device Name
Oxygen Therapy
Model / Reference
038-13-115
Primary DI / UDI-DI
05055788713616
Basic UDI-DI
B-05055788713616
EMDN Code
R0301020301 Oxygen therapy standard nasal cannulas (goggles)
Device Class
Class IIa
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000034163
Authorised representative
Flexicare EU Ops Ltd XI-AR-000048902

Other devices from Flexicare Medical Ltd.

See all devices from Flexicare Medical Ltd. →

Properties

  • Sterile

Other properties (12)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No