Australia flagARTG 391023

A2000 Multi-use Syringe Kit - Contrast medium injection system syringe

ARTG ID: 391023 · Regional Health Care Group Pty Ltd · Acist Medical Systems Inc · Class IIa · Started June 21, 2022

Good Name: Regional Health Care Group Pty Ltd - A2000 Multi-use Syringe Kit - Contrast medium injection system syringe

Device classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration information
ARTG ID
391023
Start Date
June 21, 2022
Effective Date
June 21, 2022
Sponsor
Manufacturer
Country
United States of America
Address
7905 Fuller Road, Eden Prairie, MN, 55344
Intended purpose

A2000 Multi-use Syringe Kit is used with the ACIST CVI Contrast Delivery System which intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

About this record

Access comprehensive regulatory information for A2000 Multi-use Syringe Kit - 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 391023 and sponsored by Regional Health Care Group Pty Ltd, manufactured by Acist Medical Systems Inc in United States of America. The device registration started on June 21, 2022.

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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