AViTA Corporation, 9F No. 78 Sec 1, Gwang-Fu Road, Sanchong Dist., New Taipei City 24158, TAIWAN ROC.
Primary Client Use:
Intended for self-measurement and home use
Single measurements only
The Avita BPM32 is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.
The technology used in the Avita BPM32, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
||Although equivalence to another device is claimed, this has not been tested to MDR requirements.
||Self-measurement for adults
||Equivalence claim without published evidence
Validation Publications for Equivalent Devices:
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
Kang YY, Chen Q, Liu CY, Li Y, Wang JG. Validation of the AVITA BPM17 wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2017 Aug;22(4):230-3. Epub: 2017 Apr 05. doi: 10.1097/MBP.0000000000000261. PMID: 28383290.
ESH-IP:2010 - Pass General population