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Terumo Elemano2 ES-H56

Device Name:Elemano2
Device Model:ES-H56
Manufacturer:Sole: Terumo Corporation, 2-44-1 Hatagaya, Shibuya-ku, Tokyo 151-0072, JAPAN.
Measuring functions:Blood pressure
Primary Client Use:Intended for professional use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently

The technology used in the Terumo Elemano2 ES-H56, 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.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
Japanese Society of HypertensionSelf-measurement and professional use (2017-2019)Implied equivalence to the Terumo Elemano (ES-H55)

Device Family:Terumo Elemano ES-H55J, Terumo Elemano2 ES-H56J (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 Elemano ES-H55

Tochikubo O, Nishijima K, Ohshige K, Kimura K. Accuracy and applicability of the Terumo ES-H55 double-cuff sphygmomanometer for hospital use. Blood Press Monit. 2003 Oct;8(5):203-9. PMID: 14624170.

SP10:1992 - Pass General population