Australia TGA ARTG recordSurgical/medical respirator, single-use
Australia TGA ARTG Registered Device · Crea8 Management Pty Ltd · Handan Hengyong Protective & Clean Products Co Ltd · Class I · Started March 30, 2023
Good Name: Crea8 Management Pty Ltd - Surgical/medical respirator, single-use
- Risk Class
- Class I
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- March 30, 2023
- Effective Date
- March 30, 2023
- Country
- China
- Address
- C-1-901 9 Yuhua West Road, Shijiazhuang, Hebei, 050000
A non-sterile filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the worker and patients from the transfer of microorganisms, blood, body fluids, and airborne particulate materials during medical, surgical, dental, and isolation procedures. It is typically made of multiple layers of non-woven polymers, and incorporates a forming nosepiece (metal wire); it is typically secured using elastic head straps. This is a single-use device.
Access comprehensive regulatory information for Surgical/medical respirator, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Crea8 Management Pty Ltd, manufactured by Handan Hengyong Protective & Clean Products Co Ltd in China. The device registration started on March 30, 2023.
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.