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Gown, isolation, single use

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 sponsored by Thomsen Dental Pty Ltd, manufactured by Shanghai Ristea Industries Co Ltd in China. The device registration started on May 15, 2024.

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
Class I
Gown, isolation, single use
Australia TGA ARTG Registered Device
Good Name: Thomsen Dental Pty Ltd - Gown, isolation, single use
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Intended Purpose

A multipurpose garment serves as a single-use protective garment designed to prevent the transfer of microorganisms, act as a fluid barrier between the wearer and the surrounding environment. This medical device is intended for use in healthcare settings during patient care activities to minimize the risk of cross-contamination and transmission of infectious agents. The gown provides a barrier to protect healthcare workers, patients, and individuals in various industries from potential exposure to hazardous substances, thereby contributing to infection control, contamination prevention, and overall safety in accordance with relevant regulatory standards.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 15, 2024
Effective Date
May 15, 2024
Manufacturer
Country
China
Address
Suite C Floor 31 Tower 1 Jiahui Plaza No 2601 Xietu Rd, Shanghai, 200030