Australia TGA ARTG record

Loupe, binocular

Australia TGA ARTG Registered Device · Osseo Dental · LumaDent Inc · Class I · Started July 14, 2022

Good Name: Osseo Dental - Loupe, binocular

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

Name: Osseo Dental

Manufacturer

Name: LumaDent Inc
Country: United States of America
Address: 314 W 5th Street, Carson City, NV, 89703

Intended purpose

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

About this record

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.