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Electrode, electromyograph - ARTG 429070

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 registered under ARTG number 429070 and 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.

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TGA ARTG Official Data
Class IIb
ARTG 429070
Class IIb
Electrode, electromyograph
ARTG ID: 429070
Good Name: AMBU Australia Pty Ltd - Electrode, electromyograph
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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: ยท Children: 2 years to less than 12 years ยท Adolescents: aged 12 through 21 (up to but not including the 22nd birthday) ยท Adults: age 22 and up

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
429070
Start Date
November 29, 2023
Effective Date
November 29, 2023
Manufacturer
Country
Denmark
Address
Baltorpbakken 13, Ballerup, DK-2750