Summary for ARTG Entry:
HealthSTATS Australia - HealthSTATS BPro Ambulatory Blood Pressure Monitoring System - Patient data
recorder, long-term, sphygmomanometer
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 BPro Ambulatory Blood Pressure Monitoring System - Patient data recorder, long-term,
Medical device system
36888 Patient data recorder, long-term, sphygmomanometer
The BPro® ABPM system is intended for measuring systolic pressure, diastolic pressure and pulse rate
over a period of 24 hours at preprogrammed intervals. It is intended for use at home or in doctor's office
settings on patients who are eighteen (18) years or older, who have a palpable radial pulse, 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 in) and 42 cm (16.5 in). Blood pressure and pulse rate readings
obtained using the BPro are intended for use by qualified healthcare personnel as an aid to diagnosis and
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:02:15 AEDT
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