Australia TGA ARTG record

Mask, surgical, single use

Australia TGA ARTG Registered Device · PRIVATE BRANDS PTY LTD · Crown Name (WH) United Co Ltd · Class I · Started July 28, 2020

Good Name: PRIVATE BRANDS PTY LTD - Mask, surgical, single use

Device classification

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

Registration information

Start Date: July 28, 2020
Effective Date: July 28, 2020

Sponsor

Name: PRIVATE BRANDS PTY LTD

Manufacturer

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

Intended purpose

For use by health care professionals where a risk of contaminated liquid splash may be present. The surgical mask is non sterile, and for single use only. It is suitable for applications that will not exceed the performance levels the surgical mask obtained under EN 14683:2019+AC:2019 testing.

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 PRIVATE BRANDS PTY LTD, manufactured by Crown Name (WH) United Co Ltd in China. The device registration started on July 28, 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.