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ResMed AirTouch N30i - HSA Registration DE0510066

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.

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CLASS B
DE0510066
ResMed AirTouch N30i
HSA Registration Number: DE0510066
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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.

Device 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 Owner
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