Analytical non-scalp cutaneous electrode

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

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Available from:
GE Healthcare Australia Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
322396

Public Summary

Summary for ARTG Entry:

322396

GE Healthcare Australia Pty Ltd - Analytical non-scalp cutaneous electrode

ARTG entry for

Medical Device Included Class 1

Sponsor

GE Healthcare Australia Pty Ltd

Postal Address

PO Box 5079,PARRAMATTA DC, NSW, 2150

Australia

ARTG Start Date

28/08/2019

Product category

Medical Device Class 1

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Ambu AS

Baltorpbakken 13

Ballerup, , DK-2750

Denmark

Products

1. Analytical non-scalp cutaneous electrode

Product Type

Single Device Product

Effective date

28/08/2019

GMDN

61020 Analytical non-scalp cutaneous electrode

Intended purpose

This device is intended to be used to monitor and record biopotential on the site of the skin during

procedures.

Specific Conditions

© 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 http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 02.11.2019 at 05:51:45 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.

Visit www.tga.gov.au for contact information

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