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CPAP/BiPAP nasal mask, reusable - ARTG 476526

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.

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TGA ARTG Official Data
Class IIa
ARTG 476526
Class IIa
CPAP/BiPAP nasal mask, reusable
ARTG ID: 476526
Good Name: Bird Healthcare Pty Ltd - CPAP/BiPAP nasal mask, reusable
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Intended Purpose

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.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
476526
Start Date
January 23, 2025
Effective Date
January 23, 2025
Manufacturer
Country
United States of America
Address
5 Merrill Industrial Drive, Hampton, NH, 03842