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Mask, surgical, single use - ARTG 333077

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 333077 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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TGA ARTG Official Data
Class I
ARTG 333077
Class I
Mask, surgical, single use
ARTG ID: 333077
Good Name: Sleepcraft Distributors Pty Ltd - Mask, surgical, single use
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Intended Purpose

This product is intended to be supplied to Health Services Victoria urgently for the COVID-19 crisis. Protecting healthcare staff and patients from infectious diseases Surgical face mask, Type IIR - EN14683, features include: โ€ข Pleat style with ear loops โ€ข Protective four-layer protection โ€ข Splash resistant layer protection against blood and bodily fluids Surgical Face Mask Type IIR (non sterile) EN14683 Standard 4 LAYER Size: 17.5x9.5cm

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
333077
Start Date
April 01, 2020
Effective Date
April 01, 2020
Manufacturer
Country
China
Address
66 Huichang Road Huishan Industrial Park, Wuxi, Jiangsu