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Direct ophthalmoscope eye cup

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.

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TGA ARTG Official Data
Class I
Class I
Direct ophthalmoscope eye cup
Australia TGA ARTG Registered Device
Good Name: Welch Allyn Australia Pty Limited - Direct ophthalmoscope eye cup
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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 patientโ€™s eye socket during an examination.

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
Manufacturer
Country
United States of America
Address
4341 State Street Road, SKANEATELES FALLS, NY, 13153