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Multiple ocular dimension meter

Access comprehensive regulatory information for Multiple ocular dimension meter in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Im is sponsored by Welch Allyn Australia Pty Limited, manufactured by Welch Allyn Inc in United States of America. The device registration started on March 18, 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.

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Class Im
Class Im
Multiple ocular dimension meter
Australia TGA ARTG Registered Device
Good Name: Welch Allyn Australia Pty Limited - Multiple ocular dimension meter
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Intended Purpose

The Spot Vision Screener is intended to produce optical images that can help to identify refractive errors and ocular misalignments by detecting special light reflexes from each eye during screening. The Spot Vision Screener evaluates these light reflexes from the retina to estimate refractive error. It also estimates pupil size, pupil distance and eye gaze deviation. It is intended for use on subjects six months of age through adults.

Device Classification
Risk Class
Class Im
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 18, 2022
Effective Date
March 18, 2022
Manufacturer
Country
United States of America
Address
4341 State Street Road, SKANEATELES FALLS, NY, 13153