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Citizen CHUG340
Device Model:
CHUG340
Manufacturer:
Citizen Systems Japan Co. Ltd., 6-1-12 Tanashi-cho, Nishi-Tokyo-Shi, Tokyo 188-8511, JAPAN.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Japan
Description:
The Citizen CHUG340 is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
The technology used in the Citizen CHUG340, 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.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP Japanese Society of Hypertension Self-measurement (2021-2022) Implied equivalence to the Citizen CH-463E
Device Family:
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.

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.

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