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Instrument/analyser IVDs - ARTG 475208

Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 475208 and sponsored by Abacus dx Pty Ltd, manufactured by Inpeco SA in Switzerland. The device registration started on January 08, 2025.

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 I
ARTG 475208
Class I
Instrument/analyser IVDs
ARTG ID: 475208
Good Name: Abacus dx Pty Ltd - Instrument/analyser IVDs
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Intended Purpose

The FlexLab X automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing in order to automate sample processing in the Laboratory. The System consolidates multiple Analytical instruments into a unified workstation.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
475208
Start Date
January 08, 2025
Effective Date
January 08, 2025
Manufacturer
Country
Switzerland
Address
Via Torraccia 26, Novazzano, CH-6883