Australia TGA ARTG record

Catheter, angioplasty, balloon dilatation

Australia TGA ARTG Registered Device · Compliance Management Solutions · BrosMed Medical Co Ltd · Class IIa · Started July 01, 2024

Good Name: Compliance Management Solutions - Catheter, angioplasty, balloon dilatation

Device classification

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

Registration information

Start Date: July 01, 2024
Effective Date: July 01, 2024

Sponsor

Name: Compliance Management Solutions

Manufacturer

Name: BrosMed Medical Co Ltd
Country: China
Address: 15th Building SMEs Venture Park SongShan Lake Hi-Tech, Industrial Development Zone, Dongguan, Guangdong, 523808

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.

About this record

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 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.