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Ureteral sheath

Access comprehensive regulatory information for Ureteral sheath in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Actis Medical Pty Ltd, manufactured by Bonree Medical Co Ltd in China. The device registration started on April 10, 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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Class IIa
Class IIa
Ureteral sheath
Australia TGA ARTG Registered Device
Good Name: Actis Medical Pty Ltd - Ureteral sheath
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Intended Purpose

The Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. Device is single use.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 10, 2024
Effective Date
April 10, 2024
Manufacturer
Country
China
Address
No 4 Longzhu Garden Wanmu Industrial Estate Nanlang, Zhongshan, Guangdong, 528451