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Ultrasound endoscope balloon, synthetic polymer

Access comprehensive regulatory information for Ultrasound endoscope balloon, synthetic polymer in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Steris Australia Pty Ltd, manufactured by United States Endoscopy Group Inc also T/a US Endoscopy in United States of America. The device registration started on February 16, 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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TGA ARTG Official Data
Class I
Class I
Ultrasound endoscope balloon, synthetic polymer
Australia TGA ARTG Registered Device
Good Name: Steris Australia Pty Ltd - Ultrasound endoscope balloon, synthetic polymer
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Intended Purpose

A device intended to be used for endoscopic ultrasound applications using the balloon method in the upper or lower gastrointestinal tract.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
February 16, 2022
Effective Date
February 16, 2022
Manufacturer
Country
United States of America
Address
5976 Heisley Road, MENTOR, Ohio, 44060