Australia TGA ARTG record

Home CPAP unit

Australia TGA ARTG Registered Device · Wiselink Group Pty Ltd · Guangzhou Hypnus Healthcare Co Ltd · Class IIa · Started November 08, 2019

Good Name: Wiselink Group Pty Ltd - Home CPAP unit

Device classification

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

Registration information

Start Date: November 08, 2019
Effective Date: November 08, 2019

Sponsor

Name: Wiselink Group Pty Ltd

Manufacturer

Name: Guangzhou Hypnus Healthcare Co Ltd
Country: China
Address: Rm 101-02 & 201-02 No 3 Tianfeng Road and Rm 202-03 No 5 Tianfeng Road, Science City, Development District, Guangzhou, 510530

Intended purpose

The device is indicated to provide non-invasive ventilator support to treat patients weighing over 30kg with Obstructive Sleep Apnea (OSA). ASV and Auto ASV modes can also be used for the treatment of central and/or mixed apneas, or periodic breathing. This device is intended for hospital and home use. It cannot be intended for those patients who are dependent on mechanical ventilation.

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 Wiselink Group Pty Ltd, manufactured by Guangzhou Hypnus Healthcare Co Ltd in China. The device registration started on November 08, 2019.

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.