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Eyeball fixation instrument

Access comprehensive regulatory information for Eyeball fixation instrument in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by IQ Medical, manufactured by Stephens Instruments in United States of America. The device registration started on December 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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TGA ARTG Official Data
Class I
Class I
Eyeball fixation instrument
Australia TGA ARTG Registered Device
Good Name: IQ Medical - Eyeball fixation instrument
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Intended Purpose

A reusable, hand-held manual ophthalmic surgical instrument intended to be used for fixation of the eyeball during a variety of ocular procedures. The distal end is configured as an open or closed ring with a fixed or swiveling attachment to a handle and the distal end may be smooth or have blunt teeth.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 05, 2023
Effective Date
December 05, 2023
Sponsor
Manufacturer
Country
United States of America
Address
2500 Sandersville Road, Lexington , Kentucky, 40511