Australia TGA ARTG record

Loupe, binocular

Australia TGA ARTG Registered Device · Dental101 Pty Ltd · Surgimag Co Ltd · Class I · Started August 01, 2023

Good Name: Dental101 Pty Ltd - Loupe, binocular

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: August 01, 2023
Effective Date: August 01, 2023

Sponsor

Name: Dental101 Pty Ltd

Manufacturer

Name: Surgimag Co Ltd
Country: South Korea
Address: (Palbok-dong-2-ga)-104 34 Sangni 1-gil, Deokjin-gu, Jeonju-si, Jeollabuk-do, 54882

Intended purpose

Loupes are magnifying glasses used by qualified professionals in the dental and healthcare industry to aid in magnifying the operating area and working field. They can also be connected to an external light source supplying light directly through the field of vision.

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 Dental101 Pty Ltd, manufactured by Surgimag Co Ltd in South Korea. The device registration started on August 01, 2023.

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.