Australia TGA ARTG record

Hand-held subjective ophthalmic refractometer

Australia TGA ARTG Registered Device · Optimed Pty Ltd · Shanghai Mediworks Precision Instruments Co · Class IIa · Started June 05, 2023

Good Name: Optimed Pty Ltd - Hand-held subjective ophthalmic refractometer

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: June 05, 2023
Effective Date: June 05, 2023

Sponsor

Name: Optimed Pty Ltd

Manufacturer

Name: Shanghai Mediworks Precision Instruments Co
Country: China
Address: No 7 MingPu Phase II No 3279 SanLu Road, MinHang District, Shanghai, 201100

Intended purpose

The Vision screener is intended to measure the refractive power of the eye by measuring light reflexes from the retina. It also estimates pupil size, pupil distance and eye gaze deviation

About this record

Access comprehensive regulatory information for Hand-held subjective ophthalmic refractometer 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 Shanghai Mediworks Precision Instruments Co in China. The device registration started on June 05, 2023.

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.