Australia TGA ARTG record

HoperTM PTCA balloon dilatation catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Australia TGA ARTG Registered Device · Pure Sponsor Pty Ltd · Lepu Medical Technology Beijing Co Ltd · Class III · Started May 18, 2011

Good Name: Pure Sponsor Pty Ltd - HoperTM PTCA balloon dilatation catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Device classification

Risk Class: Class III
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: May 18, 2011
Effective Date: May 18, 2011

Sponsor

Name: Pure Sponsor Pty Ltd

Manufacturer

Name: Lepu Medical Technology Beijing Co Ltd
Country: China
Address: Building 7-1 No37 Chaoqian Road, Changping District, Beijing, 102200

Intended purpose

• The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. • The balloon dilatation catheter is also indicated for post-delivery expansion of balloon expandable stents.

About this record

Access comprehensive regulatory information for HoperTM PTCA balloon dilatation catheter - Angioplasty catheter, balloon dilatation, coronary, basic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Pure Sponsor Pty Ltd, manufactured by Lepu Medical Technology Beijing Co Ltd in China. The device registration started on May 18, 2011.

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.