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Retinal optical coherence tomography system

Access comprehensive regulatory information for Retinal optical coherence tomography system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Optimed Pty Ltd, manufactured by Canon Inc in Japan. The device registration started on June 27, 2016.

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 I
Class I
Retinal optical coherence tomography system
Australia TGA ARTG Registered Device
Good Name: Optimed Pty Ltd- Retinal optical coherence tomography system
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Intended Purpose

This accessory is installed on the Canon OCT-HS100, the OCT images of the anterior segment, including the cornea and chamber angle, can be captured.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 27, 2016
Effective Date
June 27, 2016
Sponsor
Manufacturer
Country
Japan
Address
9-1 Imaikami-cho Nakahara-Ku, Kawasaki, Kanagawa, 211-8501