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CPAP - Home CPAP unit

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 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.

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Class IIa
Class IIa
CPAP - Home CPAP unit
Australia TGA ARTG Registered Device
Good Name: Bird Healthcare Pty Ltd - CPAP - Home CPAP unit
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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.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
January 14, 2022
Effective Date
January 14, 2022
Manufacturer
Country
China
Address
No 10 Chaobai Street, Yanjiao Development Zone, Sanhe City, Hebei Province, 065202