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Hand-held subjective ophthalmic refractometer - ARTG 410050

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 registered under ARTG number 410050 and 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.

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Class IIa
ARTG 410050
Class IIa
Hand-held subjective ophthalmic refractometer
ARTG ID: 410050
Good Name: Optimed Pty Ltd - Hand-held subjective ophthalmic refractometer
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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

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
410050
Start Date
June 05, 2023
Effective Date
June 05, 2023
Sponsor
Manufacturer
Country
China
Address
No 7 MingPu Phase II No 3279 SanLu Road, MinHang District, Shanghai, 201100