Australia TGA ARTG record

Mask, surgical, single use

Australia TGA ARTG Registered Device · ProClean (Supplies) Australia · Crown Name (WH) United Co Ltd · Class I · Started July 20, 2020

Good Name: ProClean (Supplies) Australia - Mask, surgical, single use

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: July 20, 2020
Effective Date: July 20, 2020

Sponsor

Name: ProClean (Supplies) Australia

Manufacturer

Name: Crown Name (WH) United Co Ltd
Country: China
Address: Changhang Building RM 1805 No 69 Yanjiang Avenue, Wuhan, Hubei, 430021

Intended purpose

GMDN 35177. A single-use, disposable face mask with ear loop made from non-woven fabric to be placed over the nose and mouth to act as a protection barrier to minimise contamination and exposure to infectious airborne agents. To be used in Health Care for use in emergency departments, dentistry, changing dressings on small wounds or healing wounds where minimal blood droplet exposure may possibly occur.

About this record

Access comprehensive regulatory information for Mask, surgical, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by ProClean (Supplies) Australia, manufactured by Crown Name (WH) United Co Ltd in China. The device registration started on July 20, 2020.

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.