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AusDiagnostics Pty Ltd - Manufacturer Profile

Explore comprehensive manufacturer profile for AusDiagnostics Pty Ltd through Pure Global AI's free EU medical device database. This company manufactures 107 medical devices registered with EUDAMED across 3 risk classes based in Australia.

This page provides detailed insights including recent registrations, risk class distribution (IVD Annex II List B: 29, IVD General: 62, Class A: 16), and complete regulatory information from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry.

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107 Devices
3 Risk Classes
AusDiagnostics Pty Ltd
Manufacturer - Australia
107
Total Devices
3
Risk Classes
2022
Earliest Version
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Recent Products (Latest 10)
Most recently updated devices in the database
Device NameRisk ClassDetail
Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Class A
Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Class A
Nucleic acid Extraction/isolation Kit IVD
Class A
Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Class A
Step 1 tubes for Faecal Pathogens B 16-well
IVD General
Step 2 Plates for Faecal Pathogens B 16-well
IVD General
Step 1 tubes for Respiratory Viruses (16-well)
IVD General
Step 2 Plates for Respiratory Viruses (16-well)
IVD General
Step 1 tubes for Upper Respiratory Pathogens 16-well
IVD General
Step 2 Plates for Upper Respiratory Pathogens 16-well
IVD General
Risk Class Distribution
Breakdown by risk classification
IVD General
62(57.9%)
IVD Annex II List B
29(27.1%)
Class A
16(15.0%)
Top Authorized Representatives
Most common authorized representatives for this manufacturer
Authorized RepresentativeDevice CountPercentageView
Advena Limited
107100.0%