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Contrast medium injection system syringe - ARTG 429774

Access comprehensive regulatory information for Contrast medium injection system syringe in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 429774 and sponsored by Guerbet Australia Pty Ltd, manufactured by Shenzhen Boon Medical Supply Co Ltd in China. The device registration started on December 05, 2023.

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 429774
Class IIa
Contrast medium injection system syringe
ARTG ID: 429774
Good Name: Guerbet Australia Pty Ltd - Contrast medium injection system syringe
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Intended Purpose

This device is intended for the injection of contrast media and saline, and compatible only with Guerbet OptiVantage Injectors and Manyfill set product. The device is intended for multi-patient use up to 12/24 hours, no reprocessing allowed.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
429774
Start Date
December 05, 2023
Effective Date
December 05, 2023
Manufacturer
Country
China
Address
No 18 Jirong Road Shenkeng Henggang Street, Longgang District, Shenzhen, 518173