Home CPAP unit - ARTG 477065
Access comprehensive regulatory information for Home CPAP unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 477065 and sponsored by Wiselink Group Pty Ltd, manufactured by Guangzhou Hypnus Healthcare Co Ltd in China. The device registration started on January 29, 2025.
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.
The device is indicated to provide non-invasive ventilator support to treat patients weighing over 30kg with Obstructive Sleep Apnea (OSA). ASV and Auto ASV modes can also be used for the treatment of central and/or mixed apneas, or periodic breathing. This device is intended for hospital and home use. It cannot be intended for those patients who are dependent on mechanical ventilation.