Australia TGA ARTG record

CPAP/BiPAP face mask, reusable

Australia TGA ARTG Registered Device · Emergo Asia Pacific Pty Ltd T/a Emergo Australia · Apex Medical Corp · Class IIa · Started July 09, 2015

Good Name: Emergo Asia Pacific Pty Ltd T/a Emergo Australia - CPAP/BiPAP face mask, reusable

Device classification

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

Registration information

Start Date: July 09, 2015
Effective Date: July 09, 2015

Sponsor

Name: Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Name: Apex Medical Corp
Country: Taiwan
Address: No 9 Min Sheng St Tu-cheng, New Taipei City, 23679

Intended purpose

The Full Face Mask is intended for use in the home environment, hospitals and care facilities by adult patients (more than 30 kg) for whom positive airway pressure (CPAP or bi-level system) has been prescribed.

About this record

Access comprehensive regulatory information for CPAP/BiPAP face mask, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Emergo Asia Pacific Pty Ltd T/a Emergo Australia, manufactured by Apex Medical Corp in Taiwan. The device registration started on July 09, 2015.

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.