Australia TGA ARTG record

Direct ophthalmoscope eye cup

Australia TGA ARTG Registered Device · Welch Allyn Australia Pty Limited · Welch Allyn Inc · Class I · Started June 01, 2021

Good Name: Welch Allyn Australia Pty Limited - Direct ophthalmoscope eye cup

Device classification

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

Registration information

Start Date: June 01, 2021
Effective Date: June 01, 2021

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 device is intended to be attached to the distal (patient-contact) end of a direct ophthalmoscope head to facilitate appropriate positioning around the patient’s eye socket during an examination.

About this record

Access comprehensive regulatory information for Direct ophthalmoscope eye cup in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Welch Allyn Australia Pty Limited, manufactured by Welch Allyn Inc in United States of America. The device registration started on June 01, 2021.

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.