While the technology used in the Citizen CH-453F, to measure blood pressure, has been claimed as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but there is no evidence provided on a validation of the other device.
|Medaval||None||Although equivalence to another device is claimed, this has not been tested to MDR requirements.|
|Japanese Society of Hypertension||Self-measurement (2016-2018)||Unpublished equivalence to Citizen CH-432B, by questionnaire|
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.
Cotte UV, Faltenbacher VH, von Willich W, Bogner JR. Trial of validation of two devices for self-measurement of blood pressure according to the European Society of Hypertension International Protocol: the Citizen CH-432B and the Citizen CH-656C. Blood Press Monit. 2008 Feb;13(1):55-62. doi: 10.1097/MBP.0b013e3282cb599a. PMID: 18199925. Erratum in: Blood Press Monit. 2008 Aug;13(4):243.
ESH-IP:2002 - Pass General population