Australia TGA ARTG record

GUIDEPLUS II - Catheter, intravascular, guiding

Australia TGA ARTG Registered Device · Nipro Australia Pty Ltd · Nipro Corporation · Class III · Started November 09, 2023

Good Name: Nipro Australia Pty Ltd - GUIDEPLUS II - Catheter, intravascular, guiding

Device classification

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

Registration information

Start Date: November 09, 2023
Effective Date: November 09, 2023

Sponsor

Name: Nipro Australia Pty Ltd

Manufacturer

Name: Nipro Corporation
Country: Japan
Address: 3-9-3 Honjo-nishi, Kita-Ku, Osaka, 531-8510

Intended purpose

The device is inserted into coronary arteries and used to guide interventional devices, etc. to affected areas in coronary arteries during procedures such as percutaneous transluminal coronary angioplasty. Notably, this product is placed in front of affected areas that are difficult for interventional devices to reach, and then used to support an interventional device.

About this record

Access comprehensive regulatory information for GUIDEPLUS II - Catheter, intravascular, guiding in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Nipro Australia Pty Ltd, manufactured by Nipro Corporation in Japan. The device registration started on November 09, 2023.

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.