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Ophthalmic refractometer, automatic - ARTG 304110

Access comprehensive regulatory information for Ophthalmic refractometer, automatic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 304110 and sponsored by Opticare Pty Ltd, manufactured by Huvitz Company Ltd in South Korea. The device registration started on June 08, 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 304110
Class IIa
Ophthalmic refractometer, automatic
ARTG ID: 304110
Good Name: Opticare Pty Ltd - Ophthalmic refractometer, automatic
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DJ Fang

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Intended Purpose

An automated ophthalmic device used to measure the refractive error of the eye with an option of Autorefraction, Keratometry, Tonometry and Pachymetry.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
304110
Start Date
June 08, 2018
Effective Date
June 08, 2018
Sponsor
Manufacturer
Country
South Korea
Address
38 Burim-ro 170beon-gil Dongan-gu Anyang-si, Gyeonggi-do, 14055