Australia TGA ARTG record

Angiographic kit

Australia TGA ARTG Registered Device · Guerbet Australia Pty Ltd · Shenzhen Boon Medical Supply Co Ltd · Class IIa · Started May 06, 2021

Good Name: Guerbet Australia Pty Ltd - Angiographic kit

Device classification

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

Registration information

Start Date: May 06, 2021
Effective Date: May 06, 2021

Sponsor

Name: Guerbet Australia Pty Ltd

Manufacturer

Name: Shenzhen Boon Medical Supply Co Ltd
Country: China
Address: No 18 Jirong Road Shenkeng Henggang Street, Longgang District, Shenzhen, 518173

Intended purpose

Sterile High-Pressure Angiographic Syringes for Single Use are intended for the injection of contrast media or saline. To be used with various high-pressure injection equipment to perform DSA (Digital Subtraction Angiography), CT (Computed Tomography), MRI (Magnetic Resonance Imaging) during examination.

About this record

Access comprehensive regulatory information for Angiographic kit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Guerbet Australia Pty Ltd, manufactured by Shenzhen Boon Medical Supply Co Ltd in China. The device registration started on May 06, 2021.

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.