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BT 2000 Automated manifold Kit with Transducer - Contrast medium injection system manifold kit - ARTG 391121

Access comprehensive regulatory information for BT 2000 Automated manifold Kit with Transducer - Contrast medium injection system manifold kit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 391121 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 22, 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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Class IIa
ARTG 391121
Class IIa
BT 2000 Automated manifold Kit with Transducer - Contrast medium injection system manifold kit
ARTG ID: 391121
Good Name: Regional Health Care Group Pty Ltd - BT 2000 Automated manifold Kit with Transducer - Contrast medium injection system manifold kit
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Intended Purpose

The BT2000 Automated manifold 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.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
391121
Start Date
June 22, 2022
Effective Date
June 22, 2022
Manufacturer
Country
United States of America
Address
7905 Fuller Road, Eden Prairie, MN, 55344