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Terumo ES-P2020DZ

Device Model:ES-P2020DZ
Manufacturer:Sole: Terumo Corporation, 2-44-1 Hatagaya, Shibuya-ku, Tokyo 151-0072, JAPAN.
Measuring functions:Blood pressure
Primary Client Use:Intended for use as a public facility
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

While the technology used in the Terumo ES-P2020DZ, to measure blood pressure, has been assessed, the results of the study have not been published and cannot be verified.

Accuracy AssessmentRecommendationBasis
MedavalNoneWhile a clinical validation is claimed, it cannot be checked properly.
Japanese Society of HypertensionSelf-measurement (2017-2019)Possibly the intended device, listed as ES-P2020, to which an internal validation of the Terumo ES-P2000 is applied without explanation

Device Family:Terumo ES-P2000J, Terumo ES-P2020DZJ, Terumo ES-P2020ZZJ (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.

Terumo ES-P2000

血圧計に関するワーキンググループ, 日本高血圧学会学術委員会 [Working Group on Sphygmomanometers, Academic Committee on Hypertension in Japan] [Test reports on the Terumo R800 and P2000] [Internet] Tokyo: JSH; 2010. Available from: www.jpnsh.jp.

JIS T 1115:2005 General population

JIS T 1115:2005 General population

There is insufficient information provided in either of two reports to enable scientific assessment.