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Aerosol face mask, rebreathing, reusable - ARTG 386296

Access comprehensive regulatory information for Aerosol face mask, rebreathing, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 386296 and sponsored by Orthotic & Prosthetic Centre Pty Ltd, manufactured by Besmed Health Business Corp in Taiwan. The device registration started on March 25, 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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TGA ARTG Official Data
Class IIa
ARTG 386296
Class IIa
Aerosol face mask, rebreathing, reusable
ARTG ID: 386296
Good Name: Orthotic & Prosthetic Centre Pty Ltd - Aerosol face mask, rebreathing, reusable
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Intended Purpose

Face mask made of silicone for use with as an attachment to a device such as Spacer Chamber, to assist with the delivery of medication.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
386296
Start Date
March 25, 2022
Effective Date
March 25, 2022
Manufacturer
Country
Taiwan
Address
No 5 Lane 116 Wu-Kong 2nd Road Wu-Ku District, New Taipei City, Taiwan, 24888