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Sponsor profile

Abbott Medical Australia Pty Ltd

Sponsor (Registration Holder)1303 devices on the TGA ARTG7 device classesAug 02, 2004 – Mar 19, 2025
VerifiedTGA · Australian Register of Therapeutic Goods
1303
Total devices
7
Device classes
2004
Earliest registration
2025
Latest registration
Regulatory footprint
Search Abbott Medical Australia Pty Ltd across other regulatory registries
ThailandEuropean UnionColombiaSouth KoreaCanadaEcuador
Recent device registrations
Latest 10 TGA ARTG device registrations
Agilis™ NxT Steerable Introducer Dual-Reach™ - Epicardial guide-catheter
ARTG 483205Manufacturer: Abbott Medical
Class III · Mar 19, 2025
Therapy Dual-8 Ablation Catheter - Cardiac radio-frequency ablation system catheter
ARTG 482926Manufacturer: Abbott Medical
Class III · Mar 18, 2025
Merlin Wand with Magnet Model 3630 - Multi-purpose electrical stimulation system programmer
ARTG 482947Manufacturer: Abbott Medical
Class III · Mar 18, 2025
Therapy Ablation Catheter - Cardiac radio-frequency ablation system catheter
ARTG 482985Manufacturer: Abbott Medical
Class III · Mar 18, 2025
Regent™ Mechanical Heart Valve with FlexCuff™ - Aortic bi-leaflet mechanical heart valve prosthesis
ARTG 482606Manufacturer: Abbott Medical
Class III · Mar 14, 2025
Regent™ Mechanical Heart Valve Sizer Set - Cardiac valve prosthesis sizer set
ARTG 482607Manufacturer: Abbott Medical
Class III · Mar 14, 2025
Adaptor, pin-indexed, reusable
ARTG 482456Manufacturer: Abbott Medical
Class I · Mar 13, 2025
Pacing/defibrillation lead stylet
ARTG 482449Manufacturer: Abbott Medical
Class IIa · Mar 13, 2025
CardioMEMS Hospital System Model CM3100 - Implantable pulmonary artery pressure monitoring system
ARTG 482465Manufacturer: Abbott Medical
Class III · Mar 13, 2025
Remote control, foot-switch
ARTG 482065Manufacturer: Abbott Medical
Class IIb · Mar 07, 2025
View all 1303 devices →
Risk class distribution
Devices by risk class
Class I1138.7% of total
Class IIa14210.9% of total
Class IIb1098.4% of total
Class III76258.5% of total
Class Is735.6% of total
Class Im20.2% of total
AIMD1027.8% of total
About this profile

Explore comprehensive sponsor profile for Abbott Medical Australia Pty Ltd through Pure Global AI's free Australia TGA ARTG medical device database. This company has sponsored 1303 medical devices registered with TGA ARTG across 7 device classes. Their sponsorship history spans from Aug 02, 2004 to Mar 19, 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 III: 762, Class IIb: 109, AIMD: 102, Class I: 113, Class IIa: 142, Class Is: 73, Class Im: 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.