Australia TGA ARTG record

Polychloroprene examination/treatment glove, non-powdered

Australia TGA ARTG Registered Device · Thermo Fisher Scientific Australia Pty Ltd · PT Medisafe Technologies · Class I · Started October 08, 2021

Good Name: Thermo Fisher Scientific Australia Pty Ltd - Polychloroprene examination/treatment glove, non-powdered

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: October 08, 2021
Effective Date: October 08, 2021

Sponsor

Name: Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Name: PT Medisafe Technologies
Country: Indonesia
Address: Jl Batang Kuis gg Tambak Rejo/Pasar IX Desa Buntu Bedimbar Tanjung Morawa, Medan, Sumatera Utara, 20362

Intended purpose

A non-sterile single-use device made of polychloroprene (neoprene) intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes.

About this record

Access comprehensive regulatory information for Polychloroprene examination/treatment glove, non-powdered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Thermo Fisher Scientific Australia Pty Ltd, manufactured by PT Medisafe Technologies in Indonesia. The device registration started on October 08, 2021.

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.