Stereotactic neuronavigation/planning system

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

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Available from:
Medilink Pty Limited
Class:
Class IIa
Authorization status:
Included
Authorization number:
290836

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Public Summary

Summary for ARTG Entry:

290836

Medilink Pty Limited - Stereotactic neuronavigation/planning system

ARTG entry for

Medical Device Included Class IIa

Sponsor

Medilink Pty Limited

Postal Address

PO Box 7117,SILVERWATER, NSW, 2128

Australia

ARTG Start Date

30/06/2017

Product category

Medical Device Class IIa

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

eemagine Medical Imaging Solutions GmbH

Gubener Strasse 47

, Berlin, 10243

Germany

Products

1. Stereotactic neuronavigation/planning system

Product Type

Medical device system

Effective date

30/06/2017

GMDN

56641 Stereotactic neuronavigation/planning system

Intended purpose

Allows users to evaluate functional organisation of the human cortex using non-invasive, navigated

transcranial magnetic stimulation (TMS). This innovative solution comes with intuitive workflows and

high-precision neuronavigation, supporting stimulators from all major TMS manufacturers.

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

Public Summary

Page 1 of

Produced at 03.11.2017 at 02:42:27 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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