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F&P Myairvo 3

by Fisher & Paykel Healthcare Limited

Ref PT300EB

Active European Union

CE MDR

Valid until

Not listed

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number94200124AIRVO3HH02ES Basic UDI-DI 09420012469151UDI-DIDate21 Jun 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Respiratory Support Device
Model / Reference
PT300EB
Primary DI / UDI-DI
09420012469151
Basic UDI-DI
94200124AIRVO3HH02ES
Direct Marketing DI
09420012469151
EMDN Code
Z1203010504 Adult and paediatric/neonatal pulmonary ventilators
Device Class
Class IIb
EU market of registration
Sweden

Manufacturer details

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

Other devices from Fisher & Paykel Healthcare, Ltd.

See all devices from Fisher & Paykel Healthcare, Ltd. →

Properties

  • CMR Substance
  • Administering Medicine

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No