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First Breath Headgear - Medium (M) - Qty 1

by Viomedex Ltd United Kingdom EUDAMED

Ref VX8013 EMDN R0301010401

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506019576VX80119A Basic UDI-DIDate13 May 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  • Withdrawn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 · synced 24 Oct 2026

Device Name
First Breath Headgear
Model / Reference
VX8013
Primary DI / UDI-DI
05060195762942
Basic UDI-DI
506019576VX80119A
EMDN Code
R0301010401 Cpap helmets and kits
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
GB-MF-000004399
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Viomedex Ltd

See all devices from Viomedex Ltd →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED d98ef276-2fa1-48ba-83d5-972fa7b271bc 61 fields · synced 24 Oct 2026