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Aerosol face mask, rebreathing - ARTG 461994

Access comprehensive regulatory information for Aerosol face mask, rebreathing in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 461994 and sponsored by Medline International Two Australia Pty Ltd, manufactured by Ningbo Shengyurui Medical Appliances Co Ltd in China. The device registration started on September 05, 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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TGA ARTG Official Data
Class IIb
ARTG 461994
Class IIb
Aerosol face mask, rebreathing
ARTG ID: 461994
Good Name: Medline International Two Australia Pty Ltd - Aerosol face mask, rebreathing
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Intended Purpose

A device using compressed air to break up medical solutions and suspensions into small aerosol droplets that can be directly inhaled from the mask.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
461994
Start Date
September 05, 2024
Effective Date
September 05, 2024
Manufacturer
Country
China
Address
No 138 Binhaisi Road Hangzhou Bay New Zone, Ningbo, Zhejiang Province, 315336