Australia flagARTG 339711

Instrument/analyser IVDs

ARTG ID: 339711 · Abbott Rapid Diagnostics Pty Ltd · Abbott Rapid Diagnostics Jena GmbH · Class I · Started July 17, 2020

Good Name: Abbott Rapid Diagnostics Pty Ltd - Instrument/analyser IVDs

Device classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD-Export
Registration information
ARTG ID
339711
Start Date
July 17, 2020
Effective Date
July 17, 2020
Sponsor
Manufacturer
Country
Germany
Address
Orlaweg 1, Jena, Germany, 07743
Intended purpose

The m-PIMA™ Analyser is a portable automated bench-top analyser for processing m-PIMA™ test cartridges.

About this record

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 339711 and sponsored by Abbott Rapid Diagnostics Pty Ltd, manufactured by Abbott Rapid Diagnostics Jena GmbH in Germany. The device registration started on July 17, 2020.

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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