EUDAMED device

AIRSENSE 11 ELITE EU

EUDAMED device 00619498391509 · ResMed PTY LTD

Key facts

Primary DI 00619498391509
Trade name AIRSENSE 11 ELITE EU
Device name AirSense 11 AutoSet , AirSense 11 Elite
Reference or catalog number 39150
Manufacturer ResMed PTY LTD
Manufacturer SRN AU-MF-000011753
Risk class Class IIa
EMDN code Z12030102
EMDN description CONTINUOUS POSITIVE PRESSURE EQUIPMENT
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Sep 17, 2025

At a glance

  • No Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

Browse all EUDAMED devices