Ultraviolet Disinfection Robot - Ultraviolet room disinfection system

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

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Available from:
Hipac Healthcare Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
322503

Public Summary

Summary for ARTG Entry:

322503

Hipac Healthcare Pty Ltd - Ultraviolet Disinfection Robot - Ultraviolet room disinfection system

ARTG entry for

Medical Device Included Class 1

Sponsor

Hipac Healthcare Pty Ltd

Postal Address

PO Box 797,GOULBURN, NSW, 2580

Australia

ARTG Start Date

30/08/2019

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

ADCO Circuits

2868 Bond Street

Rochester Hills, MI, 48309

United States Of America

Products

1. Ultraviolet Disinfection Robot - Ultraviolet room disinfection system

Product Type

Medical device system

Effective date

30/08/2019

GMDN

62893 Ultraviolet room disinfection system

Intended purpose

An automated intelligent infection prevention device that utilises Ultraviolet C (UVC) light in enclosed

environments. The device automatically senses the size, contours and characteristics of the area then

calculates and distributes a rapid, single room disinfection cycle, that kills pathogens on direct, indirect,

and shadowed surfaces.

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 05:34:38 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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