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DualGuard

by Flexicare Medical Limited EUDAMED

Active European Union

Ref 032-10-845

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05055788771241 Basic UDI-DIDate7 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  • Withdrawn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
032-10-845
Primary DI / UDI-DI
05055788771241
Basic UDI-DI
B-05055788771241
EMDN Code
R060299 Humidification systems - other
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

Other properties (13)

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