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Mask, surgical, single use

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 June 19, 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
Class I
Mask, surgical, single use
Australia TGA ARTG Registered Device
Good Name: Sleepcraft Distributors Pty Ltd - Mask, surgical, single use
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Intended Purpose

Protecting healthcare staff from infectious diseases and reccomended for use by medical personnel in surgical procedures. Surgical face mask, Type IIR EN14683 - with ties, features include: · Tie style · Protective four-layer protection · Splash resistant layer protection against blood and bodily fluids

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 19, 2020
Effective Date
June 19, 2020
Sponsor
Manufacturer
Country
China
Address
66 Huichang Road Huishan Industrial Park, Wuxi, Jiangsu