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Loupe, binocular

Access comprehensive regulatory information for Loupe, binocular in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Osseo Dental, manufactured by LumaDent Inc in United States of America. The device registration started on July 14, 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
Class I
Loupe, binocular
Australia TGA ARTG Registered Device
Good Name: Osseo Dental - Loupe, binocular
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Intended Purpose

A wearable device used to magnify a surgeons field of view by means of passive optics.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 14, 2022
Effective Date
July 14, 2022
Sponsor
Manufacturer
Country
United States of America
Address
314 W 5th Street, Carson City, NV, 89703