Citizen CHUG330

Device Model:

CHUG330

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 CHUG330 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 CHUG330, 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 Assessment	Recommendation	Basis
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 (2021-2024)	Implied equivalence to the Citizen CH-449 (previously to the Citizen CH-463E) claim without published evidence

Device Family:

Citizen CH-463EJ, Citizen CHD701J, Citizen CHUC515J, Citizen CHUC615J, Citizen CHUF311J, Citizen CHUF312-MKJ, Citizen CHUG330J, Citizen CHUG340J, Citizen CHUG360J, Citizen CHUG370J, Citizen CHUC558J
Legend: 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-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