Summary for ARTG Entry:
Koala Medical Pty Ltd - Light therapy unit, photo
ARTG entry for
Medical Device Included Class IIb
Koala Medical Pty Ltd
PO Box 1191,MONA VALE, NSW, 2103
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.
Novos Medical Systems Industry Trade Import
and Export Ltd Co
Ostim OSB Uzaycagi Caddesi Ayik ls Merkezi
B Blok No 82 A/B-5
1. Light therapy unit, photo
Single Device Product
35239 Light therapy unit, photo
To treat neonatal jaundice.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 12:31:40 AEDT
This is not an ARTG Certificate document.
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