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Citizen CHUG360
Device Model:
CHUG360
Manufacturer:
Citizen Systems Japan Co. Ltd., 6-1-12 Tanashi-cho, Nishi-Tokyo-Shi, Tokyo 188-8511, JAPAN.
Measuring functions:
Blood Pressure and PR
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 CHUG360 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 CHUG360, 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 (2020-2025) Implied equivalence to the Citizen CH-449 (previously to the Citizen CH-463E) claim without published evidence
Device Family:
Citizen CH-432BD,J, Citizen CH-452D,J, Citizen CH-461CJ, Citizen CH-463EJ, Citizen CH-432J, Citizen CH-453FJ, Citizen CH-550J, Citizen CH-551J, Citizen CH-552J, Citizen CHD701J, Citizen CHU302J, Citizen CHU501J, Citizen CHU502J, Citizen CHU703J, Citizen CHUR901J, Citizen CHUC515J, Citizen CHUC615J, Citizen CHUF311J, Citizen CHUF312-MKJ, Citizen CHUG330J, Citizen CHUG340J, Citizen CHUG360J, Citizen CHUG370J, Citizen CHUC558J, Citizen CHUN270J, Citizen CHUN380J, Citizen CHUN381J, Citizen CHUN382J, Citizen CHUN386J, Citizen CHUN2701J, Citizen CHUN3801J, Citizen CHUN271J
Legend: D DET Equivalence, J JHS Implied Equivalence
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-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

Citizen CH-461C

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

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

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