Australia TGA ARTG record

Electrode, foetal scalp

Australia TGA ARTG Registered Device · Fusion Healthcare Pty Ltd · Neoventa Medical AB · Class IIa · Started August 28, 2014

Good Name: Fusion Healthcare Pty Ltd - Electrode, foetal scalp

Device classification

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

Registration information

Start Date: August 28, 2014
Effective Date: August 28, 2014

Sponsor

Name: Fusion Healthcare Pty Ltd

Manufacturer

Name: Neoventa Medical AB
Country: Sweden
Address: Norra Agatan 32, Molndal, SE-43135

Intended purpose

Foetal Scalp Electrode(FSE): is a device placed just under the skin on the presenting part of the fetus whilst in-utero to assess the fetal heart rate (FHR) pattern when external monitoring is unable to be used or when the signal quality is poor. GMDN 35038 Electrode, foetal scalp To conduct a Foetal ecg to a CTG

About this record

Access comprehensive regulatory information for Electrode, foetal scalp in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Fusion Healthcare Pty Ltd, manufactured by Neoventa Medical AB in Sweden. The device registration started on August 28, 2014.

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.