Australia TGA ARTG record

Mask, air/oxygen

Australia TGA ARTG Registered Device · Symbion Pty Ltd · Haemologic Biotech Pty Ltd · Class IIa · Started June 27, 2017

Good Name: Symbion Pty Ltd - Mask, air/oxygen

Device classification

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

Registration information

Start Date: June 27, 2017
Effective Date: June 27, 2017

Sponsor

Name: Symbion Pty Ltd

Manufacturer

Name: Haemologic Biotech Pty Ltd
Country: Australia
Address: D2 & D3 / 15 Narabang Way, BELROSE, NSW, 2085

Intended purpose

A malleable cylinder placed over the nose and mouth intended to deliver air/oxygen gases to a patient's airway. This device is typically nonconductive and is available in a range of sizes. It may include a headstrap and various connectors and valves. it is disposable. It is to be used for respiratory therapy for home and hospital use.

About this record

Access comprehensive regulatory information for Mask, air/oxygen in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Symbion Pty Ltd, manufactured by Haemologic Biotech Pty Ltd in Australia. The device registration started on June 27, 2017.

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.