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Airsense 11 Autoset Pol

by ResMed PTY LTD

Ref 39340

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number619498EC19776 Basic UDI-DI 00619498393404UDI-DIDate18 Jan 2024RegisteredStatusActive

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  • Withdrawn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
AirSense 11 AutoSet, AirSense 11 Elite
Model / Reference
39340
Primary DI / UDI-DI
00619498393404
Basic UDI-DI
619498EC19776
Direct Marketing DI
00619498395330
EMDN Code
Z12030102 Continuous positive pressure equipment
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
AU-MF-000011753
Authorised representative
ResMed SAS FR-AR-000007151

Other devices from Resmed Pty Ltd

See all devices from Resmed Pty Ltd →

Properties

  • CMR Substance

Other properties (12)

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