Singapore HSA registration DE0509819
ResMed AirSense 11
Singapore·CLASS B·ResMed Pty Ltd·Registered September 20, 2024Device 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 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.
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 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
About this record
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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