Australia TGA ARTG record

Loupe, binocular

Australia TGA ARTG Registered Device · Osseo Dental · Changzhou Sifary Medical Technology Co Ltd · Class I · Started May 20, 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: May 20, 2022
Effective Date: May 20, 2022

Sponsor

Name: Osseo Dental

Manufacturer

Name: Changzhou Sifary Medical Technology Co Ltd
Country: China
Address: No 99 Qingyang Road Xuejia County Xinbei District, Changzhou City, Jiangsu, 213000

Intended purpose

A wearable device used to magnify a surgeons field of view by use 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 Changzhou Sifary Medical Technology Co Ltd in China. The device registration started on May 20, 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.