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Electrode, foetal scalp

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.

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Class IIa
Class IIa
Electrode, foetal scalp
Australia TGA ARTG Registered Device
Good Name: Fusion Healthcare Pty Ltd - Electrode, foetal scalp
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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

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
Manufacturer
Country
Sweden
Address
Norra Agatan 32, Molndal, SE-43135