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Catheter, angioplasty, balloon dilatation - ARTG 454065

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 454065 and sponsored by Compliance Management Solutions, manufactured by BrosMed Medical Co Ltd in China. The device registration started on July 01, 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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Class IIa
ARTG 454065
Class IIa
Catheter, angioplasty, balloon dilatation
ARTG ID: 454065
Good Name: Compliance Management Solutions - Catheter, angioplasty, balloon dilatation
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Intended Purpose

The Tri-Wedge PTA Scoring Balloon Dilatation Catheter is indicated to dilate stenoses in the femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulate.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
454065
Start Date
July 01, 2024
Effective Date
July 01, 2024
Manufacturer
Country
China
Address
15th Building SMEs Venture Park SongShan Lake Hi-Tech, Industrial Development Zone, Dongguan, Guangdong, 523808