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Gown, isolation, single use - ARTG 427402

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 Is is registered under ARTG number 427402 and sponsored by Hurst & Co Pty Ltd, manufactured by Wuhan Topmed Trading Co Ltd in China. The device registration started on November 06, 2023.

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 Is
ARTG 427402
Class Is
Gown, isolation, single use
ARTG ID: 427402
Good Name: Hurst & Co Pty Ltd - Gown, isolation, single use
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Intended Purpose

A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the healthcare provider, visitor and the patient from the transfer of infectious agents carried by other healthcare providers, patients or visitors; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected a patient. This is a single-use garment and is supplied sterile.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
427402
Start Date
November 06, 2023
Effective Date
November 06, 2023
Manufacturer
Country
China
Address
C5-1203 Rongchuangzhigu No 555 Cultural Avenue Hongshan District, Wuhan City, Hubei Province, 430070