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Speculum, eye - ARTG 396263

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 registered under ARTG number 396263 and sponsored by Bausch & Lomb Australia Pty Ltd, manufactured by Bausch & Lomb Inc in United States of America. The device registration started on September 21, 2022.

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
ARTG 396263
Class I
Speculum, eye
ARTG ID: 396263
Good Name: Bausch & Lomb Australia Pty Ltd - Speculum, eye
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Intended Purpose

A reusable surgical instrument 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 with a self-opening or adjustable mechanism.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
396263
Start Date
September 21, 2022
Effective Date
September 21, 2022
Manufacturer
Country
United States of America
Address
1400 North Goodman Street, Rochester, New York, 14609