ARTG 434550CPAP/BiPAP face mask, single-use
ARTG ID: 434550 · Fisher & Paykel Healthcare Pty Ltd · Fisher & Paykel Healthcare Ltd · Class IIb · Started January 17, 2024
Good Name: Fisher & Paykel Healthcare Pty Ltd - CPAP/BiPAP face mask, single-use
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 434550
- Start Date
- January 17, 2024
- Effective Date
- January 17, 2024
- Country
- New Zealand
- Address
- 15 Maurice Paykel Place, East Tamaki, Auckland , 2013
The mask is intended to provide an interface for application of non-invasive bi-level or continuous positive airway pressure support therapy.
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 registered under ARTG number 434550 and 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.