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SD Biosensor Inc

Manufacturer • South Korea · 24 devices on the TGA ARTG · 3 device classes · Jun 06, 2014 – Jan 08, 2025

24
Total Devices
3
Device Classes
2014
Earliest
2025
Latest
Recent device registrations
Latest 10 TGA ARTG device registrations
General laboratoryware IVDs
ARTG 475206
Class IJan 08, 2025
Sponsor: Abacus dx Pty Ltd
General laboratoryware IVDs
ARTG 475206
Class IJan 08, 2025
Sponsor: Abacus dx Pty Ltd
Multiple-viruses IVDs
ARTG 462295
Class IIbSep 17, 2024
Sponsor: Abacus dx Pty Ltd
Instrument/analyser IVDs
Class IJul 01, 2024
Sponsor: Abacus dx Pty Ltd
Instrument/analyser IVDs
ARTG 454045
Class IJul 01, 2024
Sponsor: Abacus dx Pty Ltd
Plasmodium (malaria) IVDs
Class IIbSep 27, 2023
Sponsor: Abacus dx Pty Ltd
Plasmodium (malaria) IVDs
ARTG 422690
Class IIbSep 27, 2023
Sponsor: Abacus dx Pty Ltd
Dengue virus IVDs
Class IIbSep 08, 2021
Sponsor: Abacus dx Pty Ltd
Dengue virus IVDs
ARTG 374392
Class IIbSep 08, 2021
Sponsor: Abacus dx Pty Ltd
Red cell metabolic enzyme IVDs
Class IIbApr 21, 2021
Sponsor: Biocelect Pty Ltd
View All 24 Devices →
Risk class distribution
Devices by risk class
Class I
9
37.5% of total
Class IIa
3
12.5% of total
Class IIb
12
50.0% of total
About this profile

Explore comprehensive manufacturer profile for SD Biosensor Inc through Pure Global AI's free Australia TGA ARTG medical device database. This company has manufactured 24 medical devices registered with TGA ARTG across 3 device classes. This manufacturer is based in South Korea. Their registration history spans from Jun 06, 2014 to Jan 08, 2025.

This page provides detailed insights including recent device registrations, risk class distribution (Class I: 9, Class IIb: 12, Class IIa: 3), 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 AI24 Devices3 Device Classes