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Infraredex Inc

Manufacturer • United States of America · 4 devices on the TGA ARTG · 2 device classes · Feb 04, 2022 – May 24, 2023

4
Total Devices
2
Device Classes
2022
Earliest
2023
Latest
Recent device registrations
Latest 10 TGA ARTG device registrations
DualproTM IVUS+NIRS Imaging Catheter or Dualpro Catheter - Transducer assembly; ultrasound; diagnostic; intracorporeal; intravascular; single-use
Class IIIMay 24, 2023
Sponsor: Nipro Australia Pty Ltd
DualproTM IVUS+NIRS Imaging Catheter or Dualpro Catheter - Transducer assembly; ultrasound; diagnostic; intracorporeal; intravascular; single-use
ARTG 409542
Class IIIMay 24, 2023
Sponsor: Nipro Australia Pty Ltd
Makoto Intravascular Imaging System - Ultrasound system, imaging, cardiovascular
ARTG 383511
Class IIaFeb 04, 2022
Sponsor: Nipro Australia Pty Ltd
Makoto Intravascular Imaging System - Ultrasound system, imaging, cardiovascular
Class IIaFeb 04, 2022
Sponsor: Nipro Australia Pty Ltd
Risk class distribution
Devices by risk class
Class IIa
2
50.0% of total
Class III
2
50.0% of total
About this profile

Explore comprehensive manufacturer profile for Infraredex Inc through Pure Global AI's free Australia TGA ARTG medical device database. This company has manufactured 4 medical devices registered with TGA ARTG across 2 device classes. This manufacturer is based in United States of America. Their registration history spans from Feb 04, 2022 to May 24, 2023.

This page provides detailed insights including recent device registrations, risk class distribution (Class IIa: 2, Class III: 2), and complete regulatory information 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.

Free Manufacturer ProfilePowered by Pure Global AI4 Devices2 Device Classes