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MYAIR EMEA IOS APP v4.4.0

by ResMed Corp.

Ref 22257 v4.4.0

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8401934EC188LY Basic UDI-DI 00840193400399UDI-DIDate5 Aug 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  • Withdrawn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
MyAir
Model / Reference
22257 v4.4.0
Primary DI / UDI-DI
00840193400399
Basic UDI-DI
8401934EC188LY
EMDN Code
Z1203019092 Various instruments for anaesthesia and pulmonary ventilation support - medical device software
Device Class
Class IIa
Special Device Type
Software
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000011805
Authorised representative
ResMed SAS FR-AR-000007151

Other devices from Resmed Corp

See all devices from Resmed Corp →

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