ARTG 382652

CPAP - Home CPAP unit

ARTG ID: 382652 · Bird Healthcare Pty Ltd · Xiaoniu Health Co Ltd · Class IIa · Started January 14, 2022

Good Name: Bird Healthcare Pty Ltd - CPAP - Home CPAP unit

Device classification

Risk Class: Class IIa
Product Type: Medical device system
ARTG Category: General

Registration information

ARTG ID: 382652
Start Date: January 14, 2022
Effective Date: January 14, 2022

Sponsor

Name: Bird Healthcare Pty Ltd

Manufacturer

Name: Xiaoniu Health Co Ltd
Country: China
Address: No 10 Chaobai Street, Yanjiao Development Zone, Sanhe City, Hebei Province, 065202

Intended purpose

This CPAP (Continuous Positive Airway Pressure) device is designed for the treatment of adult Obstructive Sleep Apnea (OSA), in patients weighing more than 30 kg. It is for use in the home or hospital/institutional environment.

About this record

Access comprehensive regulatory information for CPAP - 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 382652 and sponsored by Bird Healthcare Pty Ltd, manufactured by Xiaoniu Health Co Ltd in China. The device registration started on January 14, 2022.

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.