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handyscope - Dermatoscope

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.

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TGA ARTG Official Data
Class I
Class I
handyscope - Dermatoscope
Australia TGA ARTG Registered Device
Good Name: FotoFinder Australia Pty Ltd - handyscope - Dermatoscope
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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.

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
Manufacturer
Country
United States of America
Address
31521 Rancho Viejo Road, 104 San Juan Capistrano, California, 92675