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F&P Vitera

by Fisher & Paykel Healthcare Limited 7 variants

Part of a family of 12 devices: see the family page

Ref VIT1LU

F&P Vitera (VIT1LU) is a Class IIa device made by Fisher & Paykel Healthcare Limited, registered in EUDAMED on 1 Jul 2026 (Basic UDI-DI 94200124OSAMSKGS), active as of 8 Nov 2026.

Active European Union

CE MDR

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

Source EUDAMED, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number94200124OSAMSKGS Basic UDI-DI 09420012448484UDI-DIDate1 Jul 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Mask
Model / reference
VIT1LU
Primary DI / UDI-DI
09420012448484
Basic UDI-DI
94200124OSAMSKGS
EMDN code
R0301010201 Cpap masks
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
NZ-MF-000002556
Authorised representative
FISHER & PAYKEL HEALTHCARE SAS FR-AR-000000294

Similar devices in this category

Other devices filed under CPAP MASKS.

Other devices from Fisher & Paykel Healthcare Limited

See all devices from Fisher & Paykel Healthcare Limited →

Properties

Other properties (14, all answered No)