Pure Global

MRI system, <specify>

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
Class I
MRI system, <specify>
Australia TGA ARTG Registered Device
Good Name: Arcomed Pty Ltd - MRI system, <specify>
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

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
Manufacturer
Country
Switzerland
Address
Steinackerstrasse 29, Kloten, 8302