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Home CPAP unit - ARTG 476567

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 476567 and sponsored by iJoysBio Pty Ltd, manufactured by Suzhou Yuyue Medical Technology Co Ltd in China. The device registration started on January 24, 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.

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Class IIa
ARTG 476567
Class IIa
Home CPAP unit
ARTG ID: 476567
Good Name: iJoysBio Pty Ltd - Home CPAP unit
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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) and can be used in both home and hospital settings.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
476567
Start Date
January 24, 2025
Effective Date
January 24, 2025
Sponsor
Manufacturer
Country
China
Address
No 9 Jinfeng Road Suzhou Science & Technology Town, Suzhou, Jiangsu, 215163