Home BPAP Unit
Access comprehensive regulatory information for Home BPAP Unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Freyr Australia Pty Ltd, manufactured by Suzhou Yuyue Medical Technology Co Ltd in China. The device registration started on September 21, 2022.
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.
Intended Use of YH-720, YH-725 and YH-730: The YH-720, YH-725 and YH-730 Bi-level devices are indicated for treatment of sleep apnea hypopnea syndrome in patients weighing more than 66 lb (30 kg). It is intended both for home use and hospital use. The humidifier is intended for single patient use in the home environment and re-use in the hospital/institutional environment. Mask and air tube are purchased. Intended Use of YH-820, YH-825 and YH-830: The YH-820, YH-825 and YH-830 Bi-level devices are indicated for treatment of sleep apnea hypopnea syndrome in patients weighing more than 66 lb (30 kg). It is intended both for home use and hospital use. The humidifier is intended for single patient use in the home environment and re-use in the hospital / institutional environment. Mask and air tube are purchased.