Australia flagAustralia TGA ARTG record

Aerosol face mask, rebreathing, reusable

Australia TGA ARTG Registered Device · Orthotic & Prosthetic Centre Pty Ltd · Besmed Health Business Corp · Class IIa · Started March 25, 2022

Good Name: Orthotic & Prosthetic Centre Pty Ltd - Aerosol face mask, rebreathing, reusable

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

About this record

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 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.

Free DatabasePowered by Pure Global AITGA ARTG Official Data