exciplex308nm - Ultraviolet phototherapy unit

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

Buy It Now

Available from:
Key Business Services Aust Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
291955

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Public Summary

Summary for ARTG Entry:

291955

Key Business Services Aust Pty Ltd - exciplex308nm - Ultraviolet phototherapy unit

ARTG entry for

Medical Device Included Class IIb

Sponsor

Key Business Services Aust Pty Ltd

Postal Address

10 / 81 Bishop Street,KELVIN GROVE, QLD, 4059

Australia

ARTG Start Date

25/07/2017

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

Clarteis SAS

WTC2 120 route des macarons

Valbonne, Sophia Antipolis, 06 560

France

Products

1. exciplex308nm - Ultraviolet phototherapy unit

Product Type

Medical device system

Effective date

25/07/2017

GMDN

35149 Ultraviolet phototherapy unit

Intended purpose

A mains electricity (AC-powered) device with a special lamp that emits intense ultraviolet B (UVB) radiation

in a 5x5 cm square output window, intended to treat a variety of dermatological disorders (e.g., psoriasis,

vitiligo, psoriasis, atopic dermatitis, alopecia areata and mycosis fungoid.). The device is designed to be

used by medical professionals and is supplied as a hand held lamp with protective accessories such as

focusing/shielding tips and/or sheets etc.

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 10:53:57 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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