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Indirect binocular laser ophthalmoscope - ARTG 471645

Access comprehensive regulatory information for Indirect binocular laser ophthalmoscope in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 471645 and sponsored by Spectrum Surgical Pty Ltd, manufactured by Keeler Ltd in United Kingdom. The device registration started on December 04, 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 IIb
ARTG 471645
Class IIb
Indirect binocular laser ophthalmoscope
ARTG ID: 471645
Good Name: Spectrum Surgical Pty Ltd - Indirect binocular laser ophthalmoscope
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Intended Purpose

Laser Indirect Ophthalmoscope intended to be used as a method to transmit a laser beam from a laser system for use in the diagnosis and treatment of ocular pathology.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
471645
Start Date
December 04, 2024
Effective Date
December 04, 2024
Manufacturer
Country
United Kingdom
Address
Clewer Hill Road, Windsor, Berkshire, SL4 4AA