Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Paragon Healthcare Pty Ltd - Light therapy unit, photo
ARTG entry for
Medical Device Included Class IIa
Paragon Healthcare Pty Ltd
11 Dalmore Drive,Scoresby, VIC, 3179
ARTG Start Date
Medical Device Class IIa
- 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.
88-90 rue Frederic Fays
, Vlleurbanne, 69100
1. Light therapy unit, photo
Medical device system
35239 Light therapy unit, photo
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
No Specific Conditions included on Record
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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.
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