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Tympanotomy knife, single-use

Access comprehensive regulatory information for Tympanotomy knife, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by The O R Company Pty Ltd, manufactured by Surgistar Inc in United States of America. The device registration started on April 16, 2024.

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 IIa
Class IIa
Tympanotomy knife, single-use
Australia TGA ARTG Registered Device
Good Name: The O R Company Pty Ltd - Tympanotomy knife, single-use
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Intended Purpose

To make an incision through the layers of tympanic membrane. They are only to be used by licensed, trained physicians. The specific nature of the disease will determine the physicianโ€™s choice of product and the techniques used.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 16, 2024
Effective Date
April 16, 2024
Manufacturer
Country
United States of America
Address
2310 La Mirada Drive, Vista, California, 92081