Citizen Systems Japan Co. Ltd., 6-1-12 Tanashi-cho, Nishi-Tokyo-Shi, Tokyo 188-8511, JAPAN.
Primary Client Use:
Intended for self-measurement and home use
Single measurements only
Availability according to Countries or Regions:
The Citizen CHUF312-MK is an automatic 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 self-measurement and home use.
The technology used in the Citizen CHUF312-MK, 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
||Implied equivalence to the Citizen CH-463E
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.
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