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Spectral-domain optical coherence tomography system

Access comprehensive regulatory information for Spectral-domain optical coherence tomography system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Optimed Pty Ltd, manufactured by Optopol Technology Sp zoo in Poland. The device registration started on May 30, 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
Class IIa
Spectral-domain optical coherence tomography system
Australia TGA ARTG Registered Device
Good Name: Optimed Pty Ltd - Spectral-domain optical coherence tomography system
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Intended Purpose

A device aiding in the diagnosis and evaluation of posterior and anterior conditions of the eye through non-contact optical imaging. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional or three-dimensional (3-D) volume scans for analysis. The device has tomography,biometry,topographical abilities.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 30, 2018
Effective Date
May 30, 2018
Sponsor
Manufacturer
Country
Poland
Address
ul Zabia 42, Zawiercie, 42-400