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First Breath Headgear - Extra Small (XS) - Qty 10

by Viomedex Ltd EUDAMED

Active European Union

Ref VX8011/10

Regulatory status

as of 26 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  • Withdrawn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

Device Name
First Breath Headgear
Model / Reference
VX8011/10
Primary DI / UDI-DI
05060195762911
Basic UDI-DI
506019576VX80119A
EMDN Code
R0301010401 Cpap helmets and kits
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

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

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Properties

Show 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