Pure Global

CPAP/BiPAP face mask, single-use

Access comprehensive regulatory information for CPAP/BiPAP face mask, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Fisher & Paykel Healthcare Pty Ltd, manufactured by Fisher & Paykel Healthcare Ltd in New Zealand. The device registration started on January 17, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIb
Class IIb
CPAP/BiPAP face mask, single-use
Australia TGA ARTG Registered Device
Good Name: Fisher & Paykel Healthcare Pty Ltd - CPAP/BiPAP face mask, single-use
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The mask is intended to provide an interface for application of non-invasive bi-level or continuous positive airway pressure support therapy.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
January 17, 2024
Effective Date
January 17, 2024
Manufacturer
Country
New Zealand
Address
15 Maurice Paykel Place, East Tamaki, Auckland , 2013