Australia TGA ARTG record

Mask, surgical, single use

Australia TGA ARTG Registered Device · Sleepcraft Distributors Pty Ltd · Wuxi JHT Group Co Ltd · Class I · Started April 01, 2020

Good Name: Sleepcraft Distributors Pty Ltd - Mask, surgical, single use

Device classification

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

Registration information

Start Date: April 01, 2020
Effective Date: April 01, 2020

Sponsor

Name: Sleepcraft Distributors Pty Ltd

Manufacturer

Name: Wuxi JHT Group Co Ltd
Country: China
Address: 66 Huichang Road Huishan Industrial Park, Wuxi, Jiangsu

Intended purpose

The intended use of this product is supply the Health Servives Victoria urgently for the COVID-19 crisis. Surgical Face Masks Type II (Non-Sterile) Protecting healthcare staff and patients from infectious diseases Type I - EN14683 Standard, features include: •Pleat style with ear loops •Protective three-layer construction Medical face masks help prevent large particles expelled by the wearer from reaching the patient or work environment. Type I - EN14683 masks are appropriate for situations where exposure to blood and/or bodily fluids from the patient or work environment is not a risk for the healthcare worker.

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 Sleepcraft Distributors Pty Ltd, manufactured by Wuxi JHT Group Co Ltd in China. The device registration started on April 01, 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.