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Singapore HSA registration DE0017632

ResMed AirStart 10 APAP

Singapore flagSingapore·CLASS B·ResMed Pty Ltd·Registered November 11, 2015
Device classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
HSA Product Code
Refer to CRPNS
HS Code
90192000
Registration information
Registration Number
DE0017632
Registration Date
November 11, 2015
Change Notification Approval Date
April 09, 2024
Retention Due Date
November 10, 2025
Product description
The AirStart 10 APAP self-adjusting device is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 30 kg. 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 AirStart 10 APAP Air 10 DC-DC Converter HumidAir Standard HumidAir Cleanable Air 10 USB AirStart 10 APAP AirStart 10 APAP CO
Model Identifier(s)
36810 37253 37297 37299 37300 37301 37324 37365
About this record

Access comprehensive regulatory information for ResMed AirStart 10 APAP in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017632 and owned by ResMed Pty Ltd. The device was registered on November 11, 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