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Singapore HSA registration DE0502900

ResMed AirFit P30i

Singapore flagSingapore·CLASS B·ResMed Pty Ltd·Registered March 20, 2019
Device classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
Registration information
Registration Number
DE0502900
Registration Date
March 20, 2019
Change Notification Approval Date
June 01, 2022
Retention Due Date
March 19, 2026
Product description
The AirFit P30i is intended to be used by patients weighing more than 66 lb (30 kg) who have been prescribed non-invasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy. The mask is 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 30i HEADGEAR AirFit 30i STD FRAME W/ELBW AirFit 30i SML FRAME W/ELBW AirFit 30i ELBOW AIRFIT P30I STD FRAME SYS - L AIRFIT P30I SML FRAME SYS - L AIRFIT P30I STD FRAME SYS - M AIRFIT P30I SML FRAME SYS - M AIRFIT P30I STD FRAME SYS - S AIRFIT P30I SML FRAME SYS - S AirFit P30i S CUSHION AirFit P30i M CUSHION AirFit P30i L CUSHION AirFit P30i STD STPK  APAC AirFit P30i SML STPK  APAC
Model Identifier(s)
63814 63840 63841 63842 63852 63853 63854 63855 63856 63857 63861 63862 63863 63875 63876
About this record

Access comprehensive regulatory information for ResMed AirFit P30i in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502900 and owned by ResMed Pty Ltd. The device was registered on March 20, 2019.

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