Singapore HSA registration DE0505567
ResMed AirFit N30i Quiet
Singapore·CLASS B·ResMed Pty Ltd·Registered March 16, 2021Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ear, Nose & Throat
Registration information
- Registration Number
- DE0505567
- Registration Date
- March 16, 2021
- Retention Due Date
- March 15, 2026
Product description
The AirFit N30i masks are is intended to be used by patients weighing more than 30 kg who have been prescribed noninvasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy. The masks are intended for single patient re-use in the home and multi-patient re-use 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 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)
- AirFit N30i SML WIDE CUSHION AirFit N30i MEDIUM CUSHION AirFit N30i WIDE CUSHION AirFit N30i SML CUSHION AirFit 30i HEADGEAR AirFit 30i STD FRAME W/ELBW AirFit 30i SML FRAME W/ELBW AirFit 30i ELBOW AirFit N30i Quiet STD STPK APAC AirFit N30i Quiet SML STPK APAC AirFit 30i Multi-Hole Vent AirFit 30i QuietAir Vent
- Model Identifier(s)
- 63810 63811 63812 63813 63814 63840 63841 63842 63858 63859 63888 63889
About this record
Access comprehensive regulatory information for ResMed AirFit N30i Quiet in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505567 and owned by ResMed Pty Ltd. The device was registered on March 16, 2021.
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