Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
Primary Client Use:
Intended for use as a public facility
Single measurements only
Availability according to Countries or Regions:
The Omron HBP-9030 is a waiting-room blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the upper arm. It is intended for use as a public facility.
The technology used in the Omron HBP-9030, 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.
||Japanese Society of Hypertension
||Professional use (2021-2022)
||Implied equivalence to the Omron HBP-9031C
||Office use for adults (Preferred)
||Equivalence claim without published evidence
, Omron HBP-9030J,P
Legend: J JHS Implied Equivalence
, P Stride Equivalence
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.
Saito K, Hishiki Y, Takahashi H. Validation of the Omron HBP-9031C professional office blood pressure monitor in the general population according to the ANSI/AAMI/ISO 81060-2:2013 protocol. J Hum Hypertens. 2020 Oct;34(10):735-738. Epub: 2020 Jan 22. doi: 10.1038/s41371-020-0301-0. PMID: 31969675.
81060-2:2013 - Pass General population