Australia TGA ARTG record

CPAP/BiPAP nasal mask, reusable

Australia TGA ARTG Registered Device · Air Liquide Healthcare Pty Ltd · Air Liquide Medical Systems SRL · Class IIb · Started June 28, 2024

Good Name: Air Liquide Healthcare Pty Ltd - CPAP/BiPAP nasal mask, reusable

Device classification

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

Registration information

Start Date: June 28, 2024
Effective Date: June 28, 2024

Sponsor

Name: Air Liquide Healthcare Pty Ltd

Manufacturer

Name: Air Liquide Medical Systems SRL
Country: Italy
Address: Via Bisceglie 66, Milano, 20152

Intended purpose

Intended to be used at home or in a hospital setting by multiple adult patient(s) (weighing over 30 kg) or by multiple paediatric patients (weighing between 3 and 25 kg) who have been prescribed for a non-invasive positive pressure ventilation therapy (NIPPV).

About this record

Access comprehensive regulatory information for CPAP/BiPAP nasal mask, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Air Liquide Healthcare Pty Ltd, manufactured by Air Liquide Medical Systems SRL in Italy. The device registration started on June 28, 2024.

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.