Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Resmed Limited - Sleep assessment device
ARTG entry for
Medical Device Included (Export Only) Class 1
Regulatory Affairs / 1 Elizabeth Macarthur Drive,BELLA VISTA, NSW, 2153
ARTG Start Date
Medical Device Class 1
- 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.
1 Elizabeth Macarthur Drive
BELLA VISTA, NSW, 2153
1. Sleep assessment device
Single Device Product
33843 Sleep assessment device
A device for measuring and recording physiological signals for use in the assessment of sleep-related
breathing disorders. It is intended for use by trained clinicians or end users, in both inpatient and
No Specific Conditions included on Record
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Produced at 03.11.2017 at 01:00:03 AEDT
This is not an ARTG Certificate document.
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