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Catheter, angioplasty, balloon dilatation - ARTG 465665

Access comprehensive regulatory information for Catheter, angioplasty, balloon dilatation in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 465665 and sponsored by Compliance Management Solutions, manufactured by BrosMed Medical Co Ltd in China. The device registration started on October 24, 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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TGA ARTG Official Data
Class IIa
ARTG 465665
Class IIa
Catheter, angioplasty, balloon dilatation
ARTG ID: 465665
Good Name: Compliance Management Solutions - Catheter, angioplasty, balloon dilatation
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Intended Purpose

The PTA catheter is intended for dilatation of stenosis and post-deployed stent in the peripheral vasculature.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
465665
Start Date
October 24, 2024
Effective Date
October 24, 2024
Manufacturer
Country
China
Address
15th Building SMEs Venture Park SongShan Lake Hi-Tech, Industrial Development Zone, Dongguan, Guangdong, 523808