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Loupe, binocular - ARTG 388746

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 registered under ARTG number 388746 and 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.

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TGA ARTG Official Data
Class I
ARTG 388746
Class I
Loupe, binocular
ARTG ID: 388746
Good Name: Osseo Dental - Loupe, binocular
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Intended Purpose

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

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
388746
Start Date
May 20, 2022
Effective Date
May 20, 2022
Sponsor
Manufacturer
Country
China
Address
No 99 Qingyang Road Xuejia County Xinbei District, Changzhou City, Jiangsu, 213000