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CPAP/BiPAP nasal mask, reusable - ARTG 453933

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 registered under ARTG number 453933 and 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.

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TGA ARTG Official Data
Class IIb
ARTG 453933
Class IIb
CPAP/BiPAP nasal mask, reusable
ARTG ID: 453933
Good Name: Air Liquide Healthcare Pty Ltd - CPAP/BiPAP nasal mask, reusable
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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).

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
453933
Start Date
June 28, 2024
Effective Date
June 28, 2024
Manufacturer
Country
Italy
Address
Via Bisceglie 66, Milano, 20152