Australia TGA ARTG record

Home CPAP unit

Australia TGA ARTG Registered Device · Fisher & Paykel Healthcare Pty Ltd · Fisher & Paykel Healthcare Ltd · Class IIa · Started March 07, 2024

Good Name: Fisher & Paykel Healthcare Pty Ltd - Home CPAP unit

Device classification

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

Registration information

Start Date: March 07, 2024
Effective Date: March 07, 2024

Sponsor

Name: Fisher & Paykel Healthcare Pty Ltd

Manufacturer

Name: Fisher & Paykel Healthcare Ltd
Country: New Zealand
Address: 15 Maurice Paykel Place, East Tamaki, Auckland , 2013

Intended purpose

For use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory.

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 Fisher & Paykel Healthcare Pty Ltd, manufactured by Fisher & Paykel Healthcare Ltd in New Zealand. The device registration started on March 07, 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.