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Protection equipment, laser beam, eyewear, operator - ARTG 283899

Access comprehensive regulatory information for Protection equipment, laser beam, eyewear, operator in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 283899 and sponsored by Ultradent Australia Pty Ltd, manufactured by Azena Medical LLC in United States of America. The device registration started on December 21, 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
ARTG 283899
Class I
Protection equipment, laser beam, eyewear, operator
ARTG ID: 283899
Good Name: Ultradent Australia Pty Ltd - Protection equipment, laser beam, eyewear, operator
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Intended Purpose

The Safety Glasses are intended to be used by the surgical staff in an operating or treatment room where a laser is being used, in order to protect their eyes from injury during the laser surgery.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
283899
Start Date
December 21, 2016
Effective Date
December 21, 2016
Manufacturer
Country
United States of America
Address
3021 Citrus Circle ,Ste 180, Walnut Creek, California, 94598