Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Key Business Services Aust Pty Ltd - exciplex308nm - Ultraviolet phototherapy unit
ARTG entry for
Medical Device Included Class IIb
Key Business Services Aust Pty Ltd
10 / 81 Bishop Street,KELVIN GROVE, QLD, 4059
ARTG Start Date
Medical Device Class IIb
- 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.
WTC2 120 route des macarons
Valbonne, Sophia Antipolis, 06 560
1. exciplex308nm - Ultraviolet phototherapy unit
Medical device system
35149 Ultraviolet phototherapy unit
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.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 10:53:57 AEDT
This is not an ARTG Certificate document.
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