Singapore HSA registration DE0510066
ResMed AirTouch N30i
Singapore·CLASS B·ResMed Pty Ltd·Registered November 22, 2024Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ear, Nose & Throat
Registration information
- Registration Number
- DE0510066
- Registration Date
- November 22, 2024
- Retention Due Date
- November 21, 2025
Product description
The AirTouch N30i masks are intended for patients weighing more than 30 kg, who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. They are intended for single-patient reuse in the home environment and multipatient reuse in the 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
- 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)
- AirTouch N30i STD STPK APAC AirTouch N30i SML STPK APAC
- Model Identifier(s)
- 62302 62303
About this record
Access comprehensive regulatory information for ResMed AirTouch N30i in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510066 and owned by ResMed Pty Ltd. The device was registered on November 22, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B