Australia TGA ARTG record

Home CPAP unit

Australia TGA ARTG Registered Device · Freyr Australia Pty Ltd · Suzhou Yuyue Medical Technology Co Ltd · Class IIa · Started September 21, 2022

Good Name: Freyr Australia Pty Ltd - Home CPAP unit

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: September 21, 2022
Effective Date: September 21, 2022

Sponsor

Name: Freyr Australia Pty Ltd

Manufacturer

Name: Suzhou Yuyue Medical Technology Co Ltd
Country: China
Address: No 9 Jinfeng Road Suzhou Science & Technology Town, Suzhou, Jiangsu, 215163

Intended purpose

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.

About this record

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.