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Surgical microscope fluorescent angiography system - ARTG 301894

Access comprehensive regulatory information for Surgical microscope fluorescent angiography system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 301894 and sponsored by Leica Microsystems Pty Ltd, manufactured by Leica Microsystems (Schweiz) AG in Switzerland. The device registration started on April 16, 2018.

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 301894
Class IIa
Surgical microscope fluorescent angiography system
ARTG ID: 301894
Good Name: Leica Microsystems Pty Ltd - Surgical microscope fluorescent angiography system
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Intended Purpose

The GLOW800 is a Leica surgical microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area and bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and reconstructive surgery.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
301894
Start Date
April 16, 2018
Effective Date
April 16, 2018
Manufacturer
Country
Switzerland
Address
Max Schmidheiny-Strasse 201, Heerbrugg, 9435