Australia TGA ARTG record

Electrode, electromyograph

Australia TGA ARTG Registered Device · AMBU Australia Pty Ltd · Ambu AS · Class IIb · Started November 29, 2023

Good Name: AMBU Australia Pty Ltd - Electrode, electromyograph

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: November 29, 2023
Effective Date: November 29, 2023

Sponsor

Name: AMBU Australia Pty Ltd

Manufacturer

Name: Ambu AS
Country: Denmark
Address: Baltorpbakken 13, Ballerup, DK-2750

Intended purpose

Electromyography (EMG) Needle Electrode designed for Botulinum Toxin therapy during nerve block procedures. The Ambu Neuroline Inoject needle electrode is indicated for EMG guided injection of Botulinum Toxin for nerve block procedures.Intended Patient Population: · Children: 2 years to less than 12 years · Adolescents: aged 12 through 21 (up to but not including the 22nd birthday) · Adults: age 22 and up

About this record

Access comprehensive regulatory information for Electrode, electromyograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by AMBU Australia Pty Ltd, manufactured by Ambu AS in Denmark. The device registration started on November 29, 2023.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data 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, helping global MedTech companies navigate TGA regulations efficiently.