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ResMed AirMini - HSA Registration DE0019329

Access comprehensive regulatory information for ResMed AirMini in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0019329 and owned by ResMed Pty Ltd. The device was registered on June 14, 2017.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0019329
ResMed AirMini
HSA Registration Number: DE0019329
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Product Description

The AirMini self-adjusting machine is indicated for the treatment of Obstructive Sleep Apnoea (OSA) in patients weighing more than 30 kg. It is intended for home and hospital use.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0019329
Registration Date
June 14, 2017
Change Notification Approval Date
April 09, 2024
Retention Due Date
June 13, 2025
Product Owner
Short Name
ResMed Pty Ltd
Address
1 Elizabeth Macarthur Drive,, Bella Vista, NSW 2153, AUSTRALIA
Registrant
Address
3 TUAS AVENUE 2, SINGAPORE 639443
Importer
Address
11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579 11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579 4 LENG KEE ROAD, SIS BUILDING, #03-03, SINGAPORE 159088
Model Information
Model Name(s)
AirMini App iOS AirMini App Android AirMini AutoSet W APAC HumidX 50PK HumidX 3PK HumidX 6PK HumidX Plus 50PK HumidX Plus 3PK HumidX Plus 6PK AirMini Filter 1PK AirMini Filter 3PK AirMini Filter 6PK AirMini Tube N20 AirMini Setup Pack P10 AirMini Mask Pack F20 AirMini Setup Pack AirMini Drawstring Bag AirMini Filter Cover Charcoal AirMini 20W AC Adapter EU AirMini 20W AC Adapter UK AirMini Filter 50PK AirMini Battery AirMini DC/DC Converter AirMini Premium Carry Bag AirMini Hard Case AirMini Bed Caddy F20 Connector for AirMini N20 Connector for AirMini P10 Connector for AirMini AirMini Filter Cover Dove Grey P10 AirMini Frame SYS - XS P10 AirMini Frame SYS - S P10 AirMini Frame SYS - M P10 AirMini Frame SYS - L N30 AirMini Mask Pack N30 Connector for AirMini
Model Identifier(s)
22243 22244 38140 38808 38809 38810 38811 38812 38813 38814 38815 38816 38822 38823 38824 38825 38826 38827 38829 38830 38837 38838 38839 38840 38841 38842 38843 38844 38845 38848 38852 38853 38854 38855 38878 38880