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Surgical microscope fluorescence visualization software - ARTG 410350

Access comprehensive regulatory information for Surgical microscope fluorescence visualization software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 410350 and sponsored by Leica Microsystems Pty Ltd, manufactured by Leica Microsystems (Schweiz) AG in Switzerland. The device registration started on June 13, 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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Class IIa
ARTG 410350
Class IIa
Surgical microscope fluorescence visualization software
ARTG ID: 410350
Good Name: Leica Microsystems Pty Ltd - Surgical microscope fluorescence visualization software
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Intended Purpose

GLOW400 is a digital surgical microscope accessory for viewing fluorescence of fluorophores with an excitation peak between 380 nm and 430 nm and an observation comprising the long-wave blue, green, yellow and red spectrum in the spectral band greater than 444 nm. GLOW400 is intended for visualization of fluorescence with improved visualization of the anatomical background and for visualization of the enhanced fluorescence contrast.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
410350
Start Date
June 13, 2023
Effective Date
June 13, 2023
Manufacturer
Country
Switzerland
Address
Max Schmidheiny-Strasse 201, Heerbrugg, 9435