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Self-care monitoring web-based application software - ARTG 411230

Access comprehensive regulatory information for Self-care monitoring web-based application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 411230 and sponsored by Resmed Pty Ltd, manufactured by ResMed Corp in United States of America. The device registration started on June 26, 2023.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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TGA ARTG Official Data
Class IIa
ARTG 411230
Class IIa
Self-care monitoring web-based application software
ARTG ID: 411230
Good Name: Resmed Pty Ltd - Self-care monitoring web-based application software
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Intended Purpose

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
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
411230
Start Date
June 26, 2023
Effective Date
June 26, 2023
Sponsor
Manufacturer
Country
United States of America
Address
9001 Spectrum Center Blvd, San Diego, CA, 92123