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Otoscope - ARTG 480913

Access comprehensive regulatory information for Otoscope in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 480913 and sponsored by Vorotek Pty Ltd, manufactured by Vorotek Pty Ltd in Australia. The device registration started on February 26, 2025.

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 480913
Class I
Otoscope
ARTG ID: 480913
Good Name: Vorotek Pty Ltd - Otoscope
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Intended Purpose

A device for looking into the ear canal and at the eardrum, providing magnified or non-magnified visualisation and enabling pneumatic insufflation to assess tympanic membrane mobility.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
480913
Start Date
February 26, 2025
Effective Date
February 26, 2025
Sponsor
Manufacturer
Country
Australia
Address
23 Point Henry Road, Moolap, VIC, 3224