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ResMed myAir - HSA Registration DE0509820

Access comprehensive regulatory information for ResMed myAir in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509820 and owned by ResMed Corp.. The device was registered on September 20, 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
DE0509820
ResMed myAir
HSA Registration Number: DE0509820
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Product Description

myAir is a patient engagement software platform for use by patients who are prescribed a compatible ResMed device for the purpose of self-tracking therapy usage data and receiving coaching (educational videos, tips) in a personal home setting. The Personal Therapy Assistant (PTA) feature of myAir is intended for patients who are prescribed a compatible ResMed Air11 platform device to remotely simulate therapy prior to using their device with their prescribed settings. myAir is an optional software accessory to allow patients to acclimate to their therapy device.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0509820
Registration Date
September 20, 2024
Retention Due Date
September 19, 2025
Product Owner
Short Name
ResMed Corp.
Address
9001 Spectrum Center Blvd., San Diego CA 92123, UNITED STATES
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)
myAir myAir
Model Identifier(s)
22249 22250