Pure Global

Refractor, ophthalmic - ARTG 386399

Access comprehensive regulatory information for Refractor, ophthalmic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 386399 and sponsored by Opticare Pty Ltd, manufactured by Huvitz Company Ltd in South Korea. The device registration started on March 29, 2022.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
ARTG 386399
Class I
Refractor, ophthalmic
ARTG ID: 386399
Good Name: Opticare Pty Ltd - Refractor, ophthalmic
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

Digital Refractor To subjective test a personโ€™s vision using an automated lens device controlled remotely by the practitioner. Lenses are selected based on the patients response to an image

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
386399
Start Date
March 29, 2022
Effective Date
March 29, 2022
Sponsor
Manufacturer
Country
South Korea
Address
38 Burim-ro 170beon-gil Dongan-gu Anyang-si, Gyeonggi-do, 14055