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Medical device disinfectant - ARTG 285824

Access comprehensive regulatory information for Medical device disinfectant in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 285824 and sponsored by Tristel Pty Ltd, manufactured by Tristel Solutions Limited in United Kingdom. The device registration started on February 17, 2017.

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 IIb
ARTG 285824
Class IIb
Medical device disinfectant
ARTG ID: 285824
Good Name: Tristel Pty Ltd - Medical device disinfectant
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Intended Purpose

FUSE for Stella is a high-level disinfecting and sporicidal solution intended for the disinfection of medical devices including instruments such as endoscopes and ultrasound probes. The device is intended for disinfection of medical devices used in the Tristel Stella System or in a sink, tray or other receptacle. Effective against SARS-CoV-2.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
285824
Start Date
February 17, 2017
Effective Date
February 17, 2017
Sponsor
Manufacturer
Country
United Kingdom
Address
1B Lynx Business Park Fordham Road, Snailwell, Cambridgeshire, CB8 7NY