Citizen CHU-502
The technology used in the Citizen CHU-502, 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.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| 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| Japanese Society of Hypertension | Self-measurement (2016-2018) | Unpublished equivalence to Citizen CH-432B, by questionnaire | ||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.
Citizen CH-432B
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
