Mainstay Medical Australia Pty Ltd - Sponsor Profile

Explore comprehensive sponsor profile for Mainstay Medical Australia Pty Ltd through Pure Global AI's free Australia TGA ARTG medical device database. This company has sponsored 18 medical devices registered with TGA ARTG across 4 device classes. Their sponsorship history spans from Dec 16, 2016 to Feb 21, 2023.

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: 12, Class Is: 2, Class IIa: 2, AIMD: 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.

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18 Devices

4 Device Classes

Mainstay Medical Australia Pty Ltd

Sponsor (Registration Holder)

18

Total Devices

4

Device Classes

2016

Earliest

2023

Latest

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Recent Device Registrations

Latest 10 TGA ARTG device registrations

Adelante peel away introducer system - model number AP0716GW2-BX5 - Vascular introducer kit

ARTG 405210

Manufacturer: Oscor Incorporated

Adelante peel away introducer system - model number AP0716GW2-BX5 - Vascular introducer kit

Manufacturer: Oscor Incorporated

ReActiv8 Percutaneous Lead - Implantable lumbar neuromuscular electrical stimulation system lead

ARTG 327091

Manufacturer: Mainstay Medical Limited

ReActiv8 Programmer Wand - Implantable lumbar neuromuscular electrical stimulation system programmer

ARTG 327092

Manufacturer: Mainstay Medical Limited

ReActiv8 Magnet - Implantable stimulator control magnet

ARTG 327094

Manufacturer: Mainstay Medical Limited

ReActiv8 Application Software - Implantable electrical stimulation device management software

Manufacturer: Mainstay Medical Limited

ReActiv8 Magnet - Implantable stimulator control magnet

Manufacturer: Mainstay Medical Limited

ReActiv8 Percutaneous Lead - Implantable lumbar neuromuscular electrical stimulation system lead

Manufacturer: Mainstay Medical Limited

ReActiv8 Application Software - Implantable electrical stimulation device management software

ARTG 327093

Manufacturer: Mainstay Medical Limited

ReActiv8 Implantable Pulse Generator - Implantable lumbar neuromuscular electrical stimulation system pulse generator

ARTG 327089

Manufacturer: Mainstay Medical Limited

Risk Class Distribution

Devices by risk class

Class IIa

2

11.1% of total

Class III

12

66.7% of total

Class Is

2

11.1% of total

AIMD

2

11.1% of total