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Loupe

Access comprehensive regulatory information for Loupe in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Gunz Dental, manufactured by Univet Loupes SPA in Italy. The device registration started on August 17, 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
Loupe
Australia TGA ARTG Registered Device
Good Name: Gunz Dental - Loupe
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Intended Purpose

This is a body worn device that are a set of convex lenses that is intended to worn as glasses on the face that will magnify vision and concentrate the light on an area within the mouth and other body parts and objects during an examination for laboratory work, diagnosis, minor surgery, dermatology or by a person with impaired eyesight.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 17, 2021
Effective Date
August 17, 2021
Sponsor
Manufacturer
Country
Italy
Address
Via G Prati 87, Rezzato, BS, 25086