Light therapy unit, photo

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

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Available from:
Paragon Healthcare Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
291822

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Public Summary

Summary for ARTG Entry:

291822

Paragon Healthcare Pty Ltd - Light therapy unit, photo

ARTG entry for

Medical Device Included Class IIa

Sponsor

Paragon Healthcare Pty Ltd

Postal Address

11 Dalmore Drive,Scoresby, VIC, 3179

Australia

ARTG Start Date

21/07/2017

Product category

Medical Device Class IIa

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

NeoMedLight

88-90 rue Frederic Fays

, Vlleurbanne, 69100

France

Products

1. Light therapy unit, photo

Product Type

Medical device system

Effective date

21/07/2017

GMDN

35239 Light therapy unit, photo

Intended purpose

A photo therapy unit designed to a emit a blue light at a given wavelength to treat conditions such as

neonatal jaundice.it may comprise a fibreoptic light source with a flexible fibre optic cable and a

transparent blanket like pad which emits the light and covers the neonate's body. A timer is typically part of

the system.

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 11:12:18 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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