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Electrode, electrocardiograph, single use - ARTG 387618

Access comprehensive regulatory information for Electrode, electrocardiograph, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 387618 and sponsored by Airlife Australia Holdings Pty Ltd, manufactured by Vyaire Medical Oy in Finland. The device registration started on April 28, 2022.

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 I
ARTG 387618
Class I
Electrode, electrocardiograph, single use
ARTG ID: 387618
Good Name: Airlife Australia Holdings Pty Ltd - Electrode, electrocardiograph, single use
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Intended Purpose

Leg Attachment Pad is intended for use in conjunction with Fetal Spiral Electrode cables (REF 1590AAO and 1591AAO) with the GE CorometricsTM monitor and Fetal Spiral Electrode for CorometricsTM (REF 7000AAO) in the healthcare setting. Leg Attachment Pad is used as a neutral electrode on expectant mothers for internal fetal heart rate monitoring of their fetus during labor.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
387618
Start Date
April 28, 2022
Effective Date
April 28, 2022
Manufacturer
Country
Finland
Address
Kuortaneenkatu 2, Helsinki, FI-00510