Light therapy unit, photo

Main information

  • Trade name:
  • Light therapy unit, photo
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Light therapy unit, photo
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Included
  • Authorization number:
  • 221606
  • Last update:
  • 03-06-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221606

Koala Medical Pty Ltd - Light therapy unit, photo

ARTG entry for

Medical Device Included Class IIb

Sponsor

Koala Medical Pty Ltd

Postal Address

PO Box 1191,MONA VALE, NSW, 2103

Australia

ARTG Start Date

24/03/2014

Product category

Medical Device Class IIb

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

Novos Medical Systems Industry Trade Import

and Export Ltd Co

Ostim OSB Uzaycagi Caddesi Ayik ls Merkezi

B Blok No 82 A/B-5

Yenimahalle, Ankara,

Turkey

Products

1. Light therapy unit, photo

Product Type

Single Device Product

Effective date

24/03/2014

GMDN

35239 Light therapy unit, photo

Intended purpose

To treat neonatal jaundice.

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 10.11.2017 at 12:31:40 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