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NeoBip - Home BPAP unit - ARTG 465430

Access comprehensive regulatory information for NeoBip - Home BPAP unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 465430 and sponsored by Bird Healthcare Pty Ltd, manufactured by Xiaoniu Health Co Ltd in China. The device registration started on October 23, 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.

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Class IIa
ARTG 465430
Class IIa
NeoBip - Home BPAP unit
ARTG ID: 465430
Good Name: Bird Healthcare Pty Ltd - NeoBip - Home BPAP unit
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Intended Purpose

Intended for the treatment of obstructive sleep apnea (OSA) for adults or pulmonary insufficiency who need respiratory support. The device is intended for home, hospital, and other institutional environment use.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
465430
Start Date
October 23, 2024
Effective Date
October 23, 2024
Manufacturer
Country
China
Address
No 10 Chaobai Street, Yanjiao Development Zone, Sanhe City, Hebei Province, 065202