Australia TGA ARTG record

Multiple ocular dimension meter

Australia TGA ARTG Registered Device · Welch Allyn Australia Pty Limited · Welch Allyn Inc · Class Im · Started March 18, 2022

Good Name: Welch Allyn Australia Pty Limited - Multiple ocular dimension meter

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

Sponsor

Name: Welch Allyn Australia Pty Limited

Manufacturer

Name: Welch Allyn Inc
Country: United States of America
Address: 4341 State Street Road, SKANEATELES FALLS, NY, 13153

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.

About this record

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.