Tech in Motion - Jaw physiology evaluation system

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

Buy It Now

Available from:
Freyr Australia Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
339244

Public Summary

Summary for ARTG Entry:

339244

Freyr Australia Pty Ltd - Tech in Motion - Jaw physiology evaluation system

ARTG entry for

Medical Device Included Class 1

Sponsor

Freyr Australia Pty Ltd

Postal Address

46 Dora Street, Blacktown, NSW, 2148

Australia

ARTG Start Date

9/07/2020

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

ModJaw SAS

354 Voie Magellan

, Sainte-Helene-du Lac, 73800

France

Products

1 . Tech in Motion - Jaw physiology evaluation system

Product Type

Medical device system

Effective Date

9/07/2020

GMDN

47556 Jaw physiology evaluation system

Intended Purpose

Tech in Motion® is an active medical device intended to record and analyze mandibular kinematic to help diagnosis,

characterization and therapeutic planning of occlusion patterns.

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 22.07.2020 at 10:11:58 AEST

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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