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I-Sens Inc

Manufacturer • South Korea · 10 devices on the TGA ARTG · 3 device classes · Jul 03, 2014 – Apr 23, 2021

10
Total Devices
3
Device Classes
2014
Earliest
2021
Latest
Recent device registrations
Latest 10 TGA ARTG device registrations
Clinical chemistry substrate IVDs
ARTG 363170
Class IIbApr 23, 2021
Sponsor: Point Of Care Diagnostics Australia Pty Ltd
Clinical chemistry substrate IVDs
Class IIbApr 23, 2021
Sponsor: Ypsomed Australia Pty Ltd
Clinical chemistry substrate IVDs
Class IIaSep 08, 2017
Sponsor: Pharmaco Australia Ltd
Instrument/analyser IVDs
Class ISep 08, 2017
Sponsor: Pharmaco Australia Ltd
Clinical chemistry substrate IVDs
ARTG 293668
Class IIaSep 08, 2017
Sponsor: Pharmaco Australia Ltd
Instrument/analyser IVDs
ARTG 293669
Class ISep 08, 2017
Sponsor: Pharmaco Australia Ltd
Clinical chemistry substrate IVDs - Clinical chemistry substrate IVDs
ARTG 227287
Class IIbAug 27, 2014
Sponsor: Pharmaco Australia Ltd
Clinical chemistry substrate IVDs - Clinical chemistry substrate IVDs
Class IIbAug 27, 2014
Sponsor: Pharmaco Australia Ltd
Lancet, automatic
ARTG 225298
Class IJul 03, 2014
Sponsor: Pharmaco Australia Ltd
Lancet, automatic
Class IJul 03, 2014
Sponsor: Pharmaco Australia Ltd
Risk class distribution
Devices by risk class
Class I
4
40.0% of total
Class IIa
2
20.0% of total
Class IIb
4
40.0% of total
About this profile

Explore comprehensive manufacturer profile for I-Sens Inc through Pure Global AI's free Australia TGA ARTG medical device database. This company has manufactured 10 medical devices registered with TGA ARTG across 3 device classes. This manufacturer is based in South Korea. Their registration history spans from Jul 03, 2014 to Apr 23, 2021.

This page provides detailed insights including recent device registrations, risk class distribution (Class IIb: 4, Class IIa: 2, Class I: 4), 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 AI10 Devices3 Device Classes