Australia TGA ARTG record

MRI system, <specify>

Australia TGA ARTG Registered Device · Arcomed Pty Ltd · Arcomed AG · Class I · Started October 14, 2019

Good Name: Arcomed Pty Ltd - MRI system, <specify>

Device classification

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

Registration information

Start Date: October 14, 2019
Effective Date: October 14, 2019

Sponsor

Name: Arcomed Pty Ltd

Manufacturer

Name: Arcomed AG
Country: Switzerland
Address: Steinackerstrasse 29, Kloten, 8302

Intended purpose

This device is used to protect the Arcomed pumps from electromagnetic interference in environments with strong magnetic fields. This can be typically in proximity of MRI scanners. The device has a two piece docking station installed, therefore 2 x Arcomed infusion pumps can be safely operated in such an environment. The MRI shield has no external power supply.

About this record

Access comprehensive regulatory information for MRI system, <specify> in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Arcomed Pty Ltd, manufactured by Arcomed AG in Switzerland. The device registration started on October 14, 2019.

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.