Australia TGA ARTG record

handyscope - Dermatoscope

Australia TGA ARTG Registered Device · FotoFinder Australia Pty Ltd · 3 Gen LLC · Class I · Started September 04, 2020

Good Name: FotoFinder Australia Pty Ltd - handyscope - Dermatoscope

Device classification

Risk Class: Class I
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: September 04, 2020
Effective Date: September 04, 2020

Sponsor

Name: FotoFinder Australia Pty Ltd

Manufacturer

Name: 3 Gen LLC
Country: United States of America
Address: 31521 Rancho Viejo Road, 104 San Juan Capistrano, California, 92675

Intended purpose

A small hand-held battery-powered light intended to be used as a personal light source to provide light for local examination, inspection, and treatment of the patient. It may be torch-like in design and can have a magnifying lens to augment the lighting effect. It will typically be found in an examination room, doctor's office, on a medical trolley, in an emergency kit, or carried in a pocket. This is a reusable device.

About this record

Access comprehensive regulatory information for handyscope - Dermatoscope in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by FotoFinder Australia Pty Ltd, manufactured by 3 Gen LLC in United States of America. The device registration started on September 04, 2020.

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.