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Speculum, eye

Access comprehensive regulatory information for Speculum, eye in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Faro Care Pty Ltd, manufactured by Focus Ophthalmics LLC DBA Epsilon USA in United States of America. The device registration started on March 29, 2016.

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
Speculum, eye
Australia TGA ARTG Registered Device
Good Name: Faro Care Pty Ltd - Speculum, eye
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Intended Purpose

A surgical instrument that comprises of two arms joined at a pivot point, and which is available in various sizes, shapes and contours. It has a blunt distal tip and is used for expanding or stretching the tissue around the eye cavity when inserted and opened. It is used for examination or during ophthalmic surgery. It is usually made of stainless steel or Titanium with a self-opening or adjustable mechanism. It is reusable instrument.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 29, 2016
Effective Date
March 29, 2016
Manufacturer
Country
United States of America
Address
1215 W Holt Blvd Suit 200, Ontario, CA, 91762