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First Breath nCPAP Extra Small Prong

by Viomedex Ltd

Ref VX8020

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05060195763000 Basic UDI-DI 05060195763000UDI-DIDate27 Oct 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
First Breath nCPAP
Model / reference
VX8020
Primary DI / UDI-DI
05060195763000
Basic UDI-DI
B-05060195763000
EMDN code
R02010401 Cpap circuits
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU 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

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No