Summary for ARTG Entry:
USL Medical Pty Limited - Sleep assessment device
ARTG entry for
Medical Device Included Class IIa
USL Medical Pty Ltd
PO Box 1664,NORTH SYDNEY, NSW, 2059
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.
Lowenstein Medical Technology GmbH Co Kg
, Hamburg, 22525
1. Sleep assessment device
Single Device Product
33843 Sleep assessment device
It is a data recording system for registering, recording and storing biosignals. It is used to identify
sleep-related respiratory disorders and associated risk factors, as well as other sleep disorders (e.g. PLM),
to support diagnosis and for making therapy settings and checks
No Specific Conditions included on Record
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Produced at 10.11.2017 at 10:05:32 AEDT
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