Citizen CHU-703
The technology used in the Citizen CHU-703, 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Japanese Society of Hypertension | Self-measurement (2016-2018) | Unpublished equivalence to Citizen CH-463E, by questionnaire |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-463E
Broelmann H, Sprenger JC, Faltenbacher VH, Cotte UV, von Willich W, Bogner JR. Validation of two blood pressure measurement devices according to the European Society of Hypertension International Protocol: the Citizen CH-463E and the Citizen CH-461C. Blood Press Monit. 2010 Jun;15(3):158-62. doi: 10.1097/MBP.0b013e328336e9dc. PMID: 20124883.
ESH-IP:2002 - Pass General population