Summary for ARTG Entry:
HealthSTATS Australia - HealthSTATS Blood Pressure and Central Aortic Systolic Pressure Monitoring
Devices - Sphygmomanometer, electronic, automatic
ARTG entry for
Medical Device Included Class IIa
1312/576 St Kilda Road,MELBOURNE, VIC, 3004
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.
HealthSTATS International Pte Ltd
6 New Industrial Road #04-01/02
Singapore, , 536199
1. HealthSTATS Blood Pressure and Central Aortic Systolic Pressure Monitoring Devices -
Sphygmomanometer, electronic, automatic
Medical device system
16173 Automatic-inflation electronic sphygmomanometer, non-portable
An oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure, pulse rate and
Central Aortic Systolic Pressure (CASP). It is intended for user or in doctor's office settings on patients
who are eighteen (18) years or older, who do not have common arrhythmias such as atrial or ventricular
premature beats or atrial fibrillation, and whose arm circumferences are between 21 cm (8.3 inches) and
42 cm (16.5 inches). CASP, blood pressure and pulse rate readings obtained are intended for use by
qualified healthcare professionals as an aid to diagnosis and treatment.
No Specific Conditions included on Record
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