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Catheter balloon inflation system, single-use - ARTG 481827

Access comprehensive regulatory information for Catheter balloon inflation system, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 481827 and sponsored by Compliance Management Solutions, manufactured by BrosMed Medical Co Ltd in China. The device registration started on March 06, 2025.

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 Is
ARTG 481827
Class Is
Catheter balloon inflation system, single-use
ARTG ID: 481827
Good Name: Compliance Management Solutions - Catheter balloon inflation system, single-use
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DJ Fang

DJ Fang

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Intended Purpose

The device is intended to pressurize the balloon dilatation catheters in PTCA that create pressure in the balloon to dilate the blood vessel or indwelling stent in the blood vessel.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
481827
Start Date
March 06, 2025
Effective Date
March 06, 2025
Manufacturer
Country
China
Address
15th Building SMEs Venture Park SongShan Lake Hi-Tech, Industrial Development Zone, Dongguan, Guangdong, 523808