Medical/Surgical/Examination Lights - Mount, light, surgical/examination

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

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Available from:
HE Technical Services Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
290617

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Public Summary

Summary for ARTG Entry:

290617

HE Technical Services Pty Ltd - Medical/Surgical/Examination Lights - Mount, light, surgical/examination

ARTG entry for

Medical Device Included Class 1

Sponsor

HE Technical Services Pty Ltd

Postal Address

Factory 6 / 8 Concord Crescent,CARRUM DOWNS, VIC, 3201

Australia

ARTG Start Date

24/06/2017

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

Dr Mach GmbH & co

Flossmannstrasse 28

Erbersberg, Erbersberg, D85560

Germany

Products

1. Medical/Surgical/Examination Lights - Mount, light, surgical/examination

Product Type

Medical device system

Effective date

24/06/2017

GMDN

32245 Mount, light, surgical/examination

Intended purpose

Lights are intended to illuminate an examination area and surgical field on a patient's body with a high

intensity cold light. Light models are available in either mobile, wall mounted or ceiling mounted

configurations.

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 03:22:50 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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