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Manufacturer profile

AusDiagnostics Pty Ltd

EU EUDAMEDAustralia107 registered devices
VerifiedEUDAMED · official EU database
107
Total devices
3
Risk classes
2022
Earliest version
2024
Latest version
Regulatory footprint
Search AusDiagnostics Pty Ltd across other regulatory registries
ThailandColombiaSouth KoreaCanadaEcuadorSaudi Arabia
Recent products (latest 10)
Most recently updated devices in the database
Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
09343044005831
Class A
Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
09343044005848
Class A
Nucleic acid Extraction/isolation Kit IVD
09343044004780
Class A
Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
09343044005411
Class A
Step 1 tubes for Faecal Pathogens B 16-well
09343044005619
IVD General
Step 2 Plates for Faecal Pathogens B 16-well
09343044005602
IVD General
Step 1 tubes for Respiratory Viruses (16-well)
09343044005732
IVD General
Step 2 Plates for Respiratory Viruses (16-well)
09343044005749
IVD General
Step 1 tubes for Upper Respiratory Pathogens 16-well
09343044005756
IVD General
Step 2 Plates for Upper Respiratory Pathogens 16-well
09343044005763
IVD General
Risk class distribution
Breakdown by risk classification
IVD General6257.9% of total
IVD Annex II List B2927.1% of total
Class A1615.0% of total
Top authorized representatives
Most common authorized representatives for this manufacturer
Advena Limited
100.0%107 devices
About this 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.