Pure Global

Protection equipment, laser beam, eyewear, operator

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 sponsored by Ultradent Australia Pty Ltd, manufactured by Ultradent Products Inc in United States of America. The device registration started on March 13, 2024.

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
Protection equipment, laser beam, eyewear, operator
Australia TGA ARTG Registered Device
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 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
Start Date
March 13, 2024
Effective Date
March 13, 2024
Manufacturer
Country
United States of America
Address
505 West Ultradent Drive 10200 South, South Jordan, Utah, 84095