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Home CPAP unit - ARTG 443370

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 registered under ARTG number 443370 and 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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Class IIa
ARTG 443370
Class IIa
Home CPAP unit
ARTG ID: 443370
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
ARTG ID
443370
Start Date
March 07, 2024
Effective Date
March 07, 2024
Manufacturer
Country
New Zealand
Address
15 Maurice Paykel Place, East Tamaki, Auckland , 2013