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Visitor hygiene coverall - ARTG 340328

Access comprehensive regulatory information for Visitor hygiene coverall in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 340328 and sponsored by Aupro Farm Pty Ltd, manufactured by Xiantao Rhycom Non-woven Products 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.

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TGA ARTG Official Data
Class I
ARTG 340328
Class I
Visitor hygiene coverall
ARTG ID: 340328
Good Name: Aupro Farm Pty Ltd - Visitor hygiene coverall
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Intended Purpose

The non-sterile disposable medical coverall can protect medical staff from the infections in the work of contact with potentially airborne solid particulates and dusts and limited liquid splash and sprays. All joints are made by sewing machine and taped with the waterproof tape. The cap, cuffs and ankles are all sewed by four thread machine. The coveralls pass the third-party test of SGS and come up to the standard of USA AAMI PB70 and European standard EN14126, Type5 & Type 6.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
340328
Start Date
July 28, 2020
Effective Date
July 28, 2020
Manufacturer
Country
China
Address
Chuangye Road Longhuashan Sub-District, Xiantao City, Hubei Province