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Singapore HSA registration DE0502373

ResMed AirFit N30i

Singapore flagSingapore·CLASS B·ResMed Pty Ltd·Registered November 26, 2018
Device classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration information
Registration Number
DE0502373
Registration Date
November 26, 2018
Change Notification Approval Date
November 10, 2022
Retention Due Date
November 25, 2025
Product description
The AirFit N30i masks are is intended to be used by patients weighing more than 30 kg who have been prescribed non-invasive 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
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)
AirFit N30i SML WIDE CUSHION AirFit N30i MEDIUM CUSHION AirFit N30i WIDE CUSHION AirFit N30i SML CUSHION AirFit 30i HEADGEAR AirFit N30i STD STPK APAC AirFit N30i SML STPK APAC AirFit 30i STD FRAME W/ELBW AirFit 30i SML FRAME W/ELBW AirFit 30i ELBOW
Model Identifier(s)
63810 63811 63812 63813 63814 63825 63826 63840 63841 63842
About this record

Access comprehensive regulatory information for ResMed AirFit 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 DE0502373 and owned by ResMed Pty Ltd. The device was registered on November 26, 2018.

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