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The Sonata IUUS Probe Leak Tester Kit - Endoscope leak tester, mechanical

Access comprehensive regulatory information for The Sonata IUUS Probe Leak Tester Kit - Endoscope leak tester, mechanical in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Avention Global Pty Ltd, manufactured by Gynesonics Inc in United States of America. The device registration started on September 07, 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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Class I
Class I
The Sonata IUUS Probe Leak Tester Kit - Endoscope leak tester, mechanical
Australia TGA ARTG Registered Device
Good Name: Avention Global Pty Ltd - The Sonata IUUS Probe Leak Tester Kit - Endoscope leak tester, mechanical
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Intended Purpose

Accessory to the Sonataยฎ Intrauterine Ultrasound (IUUS) Probe. Consists of a manual inflation bulb and tubing with connector for attachment to the Sonataยฎ IUUS Probe Connector Cover. Intended to identify the presence of leaks in the Sonataยฎ IUUS Probe by immersing in water and visually observing for bubbles. The leak tester is intended to enhance visual inspection to verify that the structural integrity of the IUUS Probe remains intact and is therefore able to be reprocessed for next use

Device Classification
Risk Class
Class I
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
September 07, 2022
Effective Date
September 07, 2022
Manufacturer
Country
United States of America
Address
600 Chesapeake Drive, Redwood City, CA, 94063