Singapore HSA registration DE0019329
ResMed AirMini
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 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.
Product Owner
- Name
- ResMed Pty Ltd
- 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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B