Home CPAP unit
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 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-350 and YH-550: YH-350 CPAP and YH-550 self-adjusting device are indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). It is intended for home and hospital/ institutional use. YH-350 CPAP and YH-550 consist of main device, water tank, power adapter and cable. Mask and air tube are purchased. Intended Use of YH-360 and YH-560: The YH-360 CPAP and YH-560 self-adjusting device are indicated for treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). It is intended both for home and hospital/ institutional use. YH-360 CPAP and YH-560 consist of main device, water tank, power adapter and cable. Mask and air tube are purchased. Intended Use of YH-450 and YH-480: The YH-450 and YH-480 self-adjusting devices are indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). It is intended for home and hospital/institutional use. The YH-450 and the YH-480 consist of main device, water tank, power adapter and cable. Mask and air tube are purchased.