Australia TGA ARTG record

Speculum, eye

Australia TGA ARTG Registered Device · Faro Care Pty Ltd · Focus Ophthalmics LLC DBA Epsilon USA · Class I · Started March 29, 2016

Good Name: Faro Care Pty Ltd - Speculum, eye

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

Sponsor

Name: Faro Care Pty Ltd

Manufacturer

Name: Focus Ophthalmics LLC DBA Epsilon USA
Country: United States of America
Address: 1215 W Holt Blvd Suit 200, Ontario, CA, 91762

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.

About this record

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.