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Protection equipment, light therapy, eyewear

Access comprehensive regulatory information for Protection equipment, light therapy, eyewear in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Draeger Australia Pty Ltd, manufactured by Maxtec Inc in United States of America. The device registration started on February 16, 2021.

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, light therapy, eyewear
Australia TGA ARTG Registered Device
Good Name: Draeger Australia Pty Ltd - Protection equipment, light therapy, eyewear
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Intended Purpose

The EyeMax2 provides neonatal eye protection during ultraviolet (UV) phototherapy treatment of jaundice.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
February 16, 2021
Effective Date
February 16, 2021
Manufacturer
Country
United States of America
Address
2305 South 1070 West , Salt Lake City, UT, 84119