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Mainstay Medical Limited - Manufacturer Profile

Explore comprehensive manufacturer profile for Mainstay Medical Limited through Pure Global AI's free Australia TGA ARTG medical device database. This company has manufactured 16 medical devices registered with TGA ARTG across 4 device classes. This manufacturer is based in Ireland. Their registration history spans from Dec 16, 2016 to Dec 04, 2019.

This page provides detailed insights including recent device registrations, risk class distribution (Class III: 10, AIMD: 2, Class IIa: 2, 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 complete medical device registry with 131,000+ devices.

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16 Devices
4 Device Classes
Mainstay Medical Limited
Manufacturer โ€ข Ireland
16
Total Devices
4
Device Classes
2016
Earliest
2019
Latest
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Recent Device Registrations
Latest 10 TGA ARTG device registrations

ReActiv8 Activator - Implantable lumbar neuromuscular electrical stimulation system control unit

ARTG 327090

Class III
Dec 04, 2019

Sponsor: Mainstay Medical Australia Pty Ltd

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

ARTG 327089

AIMD
Dec 04, 2019

Sponsor: Mainstay Medical Australia Pty Ltd

ReActiv8 Programmer Wand - Implantable lumbar neuromuscular electrical stimulation system programmer

ARTG 327092

Class III
Dec 04, 2019

Sponsor: Mainstay Medical Australia Pty Ltd

ReActiv8 Magnet - Implantable stimulator control magnet

ARTG 327094

Class III
Dec 04, 2019

Sponsor: Mainstay Medical Australia Pty Ltd

ReActiv8 Application Software - Implantable electrical stimulation device management software

Class III
Dec 04, 2019

Sponsor: Mainstay Medical Australia Pty Ltd

ReActiv8 Magnet - Implantable stimulator control magnet

Class III
Dec 04, 2019

Sponsor: Mainstay Medical Australia Pty Ltd

ReActiv8 Activator - Implantable lumbar neuromuscular electrical stimulation system control unit

Class III
Dec 04, 2019

Sponsor: Mainstay Medical Australia Pty Ltd

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

AIMD
Dec 04, 2019

Sponsor: Mainstay Medical Australia Pty Ltd

ReActiv8 Percutaneous Lead - Implantable lumbar neuromuscular electrical stimulation system lead

Class III
Dec 04, 2019

Sponsor: Mainstay Medical Australia Pty Ltd

ReActiv8 Programmer Wand - Implantable lumbar neuromuscular electrical stimulation system programmer

Class III
Dec 04, 2019

Sponsor: Mainstay Medical Australia Pty Ltd

Risk Class Distribution
Devices by risk class
Class IIa
2
12.5% of total
Class III
10
62.5% of total
Class Is
2
12.5% of total
AIMD
2
12.5% of total