Pure Global

Home CPAP unit

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.

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TGA ARTG Official Data
Class IIa
Class IIa
Home CPAP unit
Australia TGA ARTG Registered Device
Good Name: Fisher & Paykel Healthcare Pty Ltd - Home CPAP unit
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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.

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
Manufacturer
Country
New Zealand
Address
15 Maurice Paykel Place, East Tamaki, Auckland , 2013