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HoperTM PTCA balloon dilatation catheter - Angioplasty catheter, balloon dilatation, coronary, basic - ARTG 183453

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 registered under ARTG number 183453 and 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.

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Class III
ARTG 183453
Class III
HoperTM PTCA balloon dilatation catheter - Angioplasty catheter, balloon dilatation, coronary, basic
ARTG ID: 183453
Good Name: Pure Sponsor Pty Ltd - HoperTM PTCA balloon dilatation catheter - Angioplasty catheter, balloon dilatation, coronary, basic
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Intended Purpose

โ€ข 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. โ€ข The balloon dilatation catheter is also indicated for post-delivery expansion of balloon expandable stents.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
183453
Start Date
May 18, 2011
Effective Date
May 18, 2011
Manufacturer
Country
China
Address
Building 7-1 No37 Chaoqian Road, Changping District, Beijing, 102200