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Singapore HSA registration DE0504897

ResMed AirFit N30

Singapore flagSingapore·CLASS B·ResMed Pty Ltd·Registered September 09, 2020
Device classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration information
Registration Number
DE0504897
Registration Date
September 09, 2020
Retention Due Date
September 08, 2025
Product description
The AirFit N30 nasal cradle mask 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 mask is intended for single patient re-use in the home and multipatient 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
SG MEDICAL PTE LTD
Address
4 LENG KEE ROAD, SIS BUILDING, #03-03, SINGAPORE 159088
Model information
Model Name(s)
AirFit N30 Mask SYS APAC AirFit N30 Cushion SMALL AirFit N30 Cushion MEDIUM AirFit N30 Cushion SMALL-WIDE AirFit N30 Headgear AirFit N30 Frame
Model Identifier(s)
64206 64213 64214 64215 64216 64219
About this record

Access comprehensive regulatory information for ResMed AirFit N30 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504897 and owned by ResMed Pty Ltd. The device was registered on September 09, 2020.

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