Australia TGA ARTG record

Ultrasound endoscope balloon, synthetic polymer

Australia TGA ARTG Registered Device · Steris Australia Pty Ltd · United States Endoscopy Group Inc also T/a US Endoscopy · Class I · Started February 16, 2022

Good Name: Steris Australia Pty Ltd - Ultrasound endoscope balloon, synthetic polymer

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

Sponsor

Name: Steris Australia Pty Ltd

Manufacturer

Name: United States Endoscopy Group Inc also T/a US Endoscopy
Country: United States of America
Address: 5976 Heisley Road, MENTOR, Ohio, 44060

Intended purpose

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

About this record

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.