Operating room device management system

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

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Available from:
Hoyland Medical Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
293736

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Public Summary

Summary for ARTG Entry:

293736

Hoyland Medical Pty Ltd - Operating room device management system

ARTG entry for

Medical Device Included Class 1

Sponsor

Hoyland Medical Pty Ltd

Postal Address

Unit 7 / 22 Palmer Place,MURARRIE, QLD, 4172

Australia

ARTG Start Date

11/09/2017

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

Merivaara Instrumentarium

Puustellintie 2

LAHTI, , 15150

Finland

Products

1. Operating room device management system

Product Type

Single Device Product

Effective date

11/09/2017

GMDN

58117 Operating room device management system

Intended purpose

Open OR is a revolutionary open architecture management system that integrates operating room devices,

data and image management in response to the needs of the surgical department. Based on open

architecture and modularity, OpenOR helps sync and store information as well transport via wireless or

hard wired surgical and patient information. It can control the Air conditioning, lights both theatre and room,

education, microphones and more.

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 03:27:12 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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