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Sponsor profile

Abacus dx Pty Ltd

Sponsor (Registration Holder)470 devices on the TGA ARTG5 device classesJun 26, 2007 – Feb 28, 2025
VerifiedTGA · Australian Register of Therapeutic Goods
470
Total devices
5
Device classes
2007
Earliest registration
2025
Latest registration
Regulatory footprint
Search Abacus dx Pty Ltd across other regulatory registries
ThailandEuropean UnionColombiaSouth KoreaCanadaEcuador
Recent device registrations
Latest 10 TGA ARTG device registrations
Devyser RHD 8-R060-78 8-R060-390 - Foetal blood group genotyping IVD, kit, nucleic acid technique (NAT)
ARTG 481205Manufacturer: Devyser AB
Class III · Feb 28, 2025
General laboratoryware IVDs
ARTG 475206Manufacturer: SD Biosensor Inc
Class I · Jan 08, 2025
Instrument/analyser IVDs
ARTG 475209Manufacturer: Inpeco SA
Class I · Jan 08, 2025
General laboratoryware IVDs
ARTG 475206Manufacturer: SD Biosensor Inc
Class I · Jan 08, 2025
Instrument/analyser IVDs
ARTG 475208Manufacturer: Inpeco SA
Class I · Jan 08, 2025
Instrument/analyser IVDs
ARTG 475209Manufacturer: Inpeco SA
Class I · Jan 08, 2025
Instrument/analyser IVDs
ARTG 475208Manufacturer: Inpeco SA
Class I · Jan 08, 2025
Troponin IVDs
ARTG 474565Manufacturer: Response Biomedical Corporation
Class IIb · Dec 23, 2024
Specimen receptacle IVDs
ARTG 474587Manufacturer: Longhorn Vaccines and Diagnostics LLC
Class I · Dec 23, 2024
Clinical chemistry hormone IVDs
ARTG 474567Manufacturer: Response Biomedical Corporation
Class IIa · Dec 23, 2024
View all 470 devices →
Risk class distribution
Devices by risk class
Class I16134.3% of total
Class IIa21545.7% of total
Class IIb9119.4% of total
Class III10.2% of total
Class Is20.4% of total
About this profile

Explore comprehensive sponsor profile for Abacus dx Pty Ltd through Pure Global AI's free Australia TGA ARTG medical device database. This company has sponsored 470 medical devices registered with TGA ARTG across 5 device classes. Their sponsorship history spans from Jun 26, 2007 to Feb 28, 2025.

In Australia, the sponsor is the legal entity responsible for the medical device's compliance with TGA regulations and ARTG registration. This page provides detailed insights including recent device registrations, risk class distribution (Class I: 161, Class IIa: 215, Class IIb: 91, Class III: 1, Class Is: 2), and complete regulatory information from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's medical device registry with 62k records.