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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 Quintessa Holdings Pty Ltd, manufactured by Cetro Medical AB in Sweden. The device registration started on June 08, 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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Class IIa
Class IIa
Electrode, foetal scalp
Australia TGA ARTG Registered Device
Good Name: Quintessa Holdings Pty Ltd - Electrode, foetal scalp
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Intended Purpose

Sterile, single use electrode intended to be attached to the fetal scalp by healthcare professionals during delivery surveillance. For use on patients requiring fetal heart rate monitoring during labor.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 08, 2023
Effective Date
June 08, 2023
Manufacturer
Country
Sweden
Address
Nitgatan 11, Smalandsstenar, Sverige, 33333