ARTG 476526CPAP/BiPAP nasal mask, reusable
ARTG ID: 476526 · Bird Healthcare Pty Ltd · Sleepnet Corporation · Class IIa · Started January 23, 2025
Good Name: Bird Healthcare Pty Ltd - CPAP/BiPAP nasal mask, reusable
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 476526
- Start Date
- January 23, 2025
- Effective Date
- January 23, 2025
- Country
- United States of America
- Address
- 5 Merrill Industrial Drive, Hampton, NH, 03842
Intended to provide a patient interface for application of positive pressure therapy. The mask is to be used as an accessory to CPAP or Bi-level positive pressure systems. It is intended for patients >2 years old and <12 years old. It is intended for single patient, multi-use in the home, hospital, or institutional environment.
Access comprehensive regulatory information for CPAP/BiPAP nasal mask, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 476526 and sponsored by Bird Healthcare Pty Ltd, manufactured by Sleepnet Corporation in United States of America. The device registration started on January 23, 2025.
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.