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Gown, isolation, single use - ARTG 387647

Access comprehensive regulatory information for Gown, isolation, 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 387647 and sponsored by Mediflex Industries Pty Ltd, manufactured by Wuhan Kangshou Medical Material Co Ltd in China. The device registration started on April 29, 2022.

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 387647
Class I
Gown, isolation, single use
ARTG ID: 387647
Good Name: Mediflex Industries Pty Ltd - Gown, isolation, single use
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Intended Purpose

A multipurpose garment, made of natural, synthetic or a combination of materials, worn by healthcare providers or visitors to isolate them from the patient. The isolation gown protects the patient, e.g. burn patients, from the transfer of infectious agents carried by the healthcare provider or visitor; or it can protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a disposable garment.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
387647
Start Date
April 29, 2022
Effective Date
April 29, 2022
Manufacturer
Country
China
Address
982 Hannan street, Hannan WUHAN, Hubei, 430000