Australia TGA ARTG record

Ureteral sheath

Australia TGA ARTG Registered Device · Actis Medical Pty Ltd · Bonree Medical Co Ltd · Class IIa · Started April 10, 2024

Good Name: Actis Medical Pty Ltd - Ureteral sheath

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

Sponsor

Name: Actis Medical Pty Ltd

Manufacturer

Name: Bonree Medical Co Ltd
Country: China
Address: No 4 Longzhu Garden Wanmu Industrial Estate Nanlang, Zhongshan, Guangdong, 528451

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.

About this record

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.