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Nebulizer, ultrasonic - ARTG 294351

Access comprehensive regulatory information for Nebulizer, ultrasonic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 294351 and sponsored by Le Reve HealthCare Pty Ltd (AKA Caremax), manufactured by Changzhou Zhengyuan Medical Technology Co Ltd in China. The device registration started on September 26, 2017.

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 294351
Class IIa
Nebulizer, ultrasonic
ARTG ID: 294351
Good Name: Le Reve HealthCare Pty Ltd (AKA Caremax) - Nebulizer, ultrasonic
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DJ Fang

DJ Fang

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Intended Purpose

The device is designed for respiratory diseases treatment and respiratory tract infection prevention. It is widely used in curing diseases of respiratory system, such as cold, fever, bronchitis, asthma, pneumonia, pneumoconiosis and pulmonary heart disease. It can also be used to cure occupational disease; give throat care to the artists, cure ENT (ear, nose, throat) diseases like chronic allergic rhinitis, acute laryngitis, acute pharyngitis, acute tonsillitis, etc.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
294351
Start Date
September 26, 2017
Effective Date
September 26, 2017
Manufacturer
Country
China
Address
Northeast 3/4/5 Floor C1 Block No9 Changyang Road, WestTaihu Lake Industrial Park Changzhou, Jiangsu, 213145