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ResMed AirSense 11 - HSA Registration DE0509819

Access comprehensive regulatory information for ResMed AirSense 11 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509819 and owned by ResMed Pty Ltd. The device was registered on September 20, 2024.

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
DE0509819
ResMed AirSense 11
HSA Registration Number: DE0509819
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Product Description

The AirSense 11 self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (30 kg). The AirSense 11 self-adjusting system is intended for home and hospital use.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0509819
Registration Date
September 20, 2024
Retention Due Date
September 19, 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 17 KAKI BUKIT PLACE, EUNOS TECHPARK, #---, SINGAPORE 416195 7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880 4 LENG KEE ROAD, SIS BUILDING, #03-03, SINGAPORE 159088 111 SOMERSET ROAD, 111 SOMERSET, #04-26, SINGAPORE 238164
Model Information
Model Name(s)
SlimLine Tubing ClimateLineAir 11 ROW HumidAir11 Cleanable ROW AirSense 11 AutoSet APAC TRI Air11 Filter, Hypo, 1 Pack Air11 Filter, Hypo, 2 Pack Air11 Filter, Hypo, 12 Pack Air11 Filter, Hypo, 50 Pack
Model Identifier(s)
36810 39104 39112 39133 39304 39305 39306 39307