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Singapore HSA registration DE0017390

ResMed AirSense 10 AutoSet

Singapore flagSingapore·CLASS B·ResMed Pty Ltd·Registered August 05, 2015
Device classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
HSA Product Code
Refer to CRPNS
HS Code
90192000
Registration information
Registration Number
DE0017390
Registration Date
August 05, 2015
Change Notification Approval Date
December 23, 2024
Retention Due Date
August 04, 2025
Product description
The AirSense 10 AutoSet self-adjusting device is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 30kg. It is intended for home and hospital use. The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.
Product Owner
Name
ResMed Pty Ltd
Short Name
ResMed Pty Ltd
Address
1 Elizabeth Macarthur Drive,, Bella Vista, NSW 2153, AUSTRALIA
Registrant
Name
ResMed Asia Pte. Ltd.
Address
3 TUAS AVENUE 2, SINGAPORE 639443
Importer
Name
EASMED ASIA PTE LTD EASMED PTE LTD SG MEDICAL PTE LTD
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)
SlimLine Tubing ClimateLineAir Air 10 DC-DC Converter HumidAir Standard Tub HumidAir Cleanable Tub Air 10 USB Air 10 Oximetry AirSense 10 AutoSet AirSense 10 AutoSet AirSense 10 AutoSet
Model Identifier(s)
36810 37296 37297 37299 37300 37301 37302 37367 37453 37493
About this record

Access comprehensive regulatory information for ResMed AirSense 10 AutoSet in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017390 and owned by ResMed Pty Ltd. The device was registered on August 05, 2015.

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