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Mask, surgical, single use - ARTG 333076

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 registered under ARTG number 333076 and 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.

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Class I
ARTG 333076
Class I
Mask, surgical, single use
ARTG ID: 333076
Good Name: Sleepcraft Distributors Pty Ltd - Mask, surgical, single use
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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: โ€ขPleat style with ear loops โ€ขProtective 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.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
333076
Start Date
April 01, 2020
Effective Date
April 01, 2020
Manufacturer
Country
China
Address
66 Huichang Road Huishan Industrial Park, Wuxi, Jiangsu