Cable/lead, electroencephalograph

Australia - English - Department of Health (Therapeutic Goods Administration)

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GE Healthcare Australia Pty Ltd
Class IIb
Authorization status:
Authorization number:

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Public Summary

Summary for ARTG Entry:


GE Healthcare Australia Pty Ltd - Cable/lead, electroencephalograph

ARTG entry for

Medical Device Included Class IIb


GE Healthcare Australia Pty Ltd

Postal Address

PO Box 5079,PARRAMATTA DC, NSW, 2150


ARTG Start Date


Product category

Medical Device Class IIb



Approval area

Medical Devices


- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.




GE Healthcare Finland Oy

Kuortaneenkatu 2

, Helsinki, FI-00510



1. Cable/lead, electroencephalograph

Product Type

Single Device Product

Effective date



35749 Cable/lead, electroencephalograph

Intended purpose

These wire(s) are intended to connect an electroencephalographic electrode(s) to an

electroencephalographic system to facilitate the transmission of the electrical signals captured at the site

of the electrode to the system for measuring, recording, monitoring and/or analysis. The procedure is

performed to record, monitor, and/or analyse the brain's electrical activity. This is a reusable device.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at

Public Summary

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Produced at 03.11.2017 at 03:40:22 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

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