ARTG 480867

Home CPAP unit

ARTG ID: 480867 · Plus Medical Pty Ltd · Suzhou Yuyue Medical Technology Co Ltd · Class IIa · Started February 26, 2025

Good Name: Plus Medical Pty Ltd - Home CPAP unit

Device classification

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

Registration information

ARTG ID: 480867
Start Date: February 26, 2025
Effective Date: February 26, 2025

Sponsor

Name: Plus Medical 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

This device can improve the quality of sleep for individuals by delivering positive airway pressure. It is intended for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing over 66 lb (30 kg). It is intended for home and hospital/institutional use.

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 registered under ARTG number 480867 and sponsored by Plus Medical Pty Ltd, manufactured by Suzhou Yuyue Medical Technology Co Ltd in China. The device registration started on February 26, 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.