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Omron HBP-T105S-N

Device Model:HBP-T105S-N
Manufacturer:Sole: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
Measuring functions:Blood pressure
Primary Client Use:Intended for professional use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the Omron HBP-T105S-N, 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 HypertensionProfessional use (2016-2018)Implied equivalence to the Omron HBP-T105, Pic Solution Professional Check, BP10

Device Family:Omron HBP-T105J, Omron HBP-T105S-NJ (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.

Omron HBP-T105

Asmar R, Khabouth J, Mattar J, Pecchioli V, Germano G. Validation of three professional devices measuring office blood pressure according to three different methods: the Omron BP10, the Omron HBP T105 and the Pic Indolor Professional. J Hypertens. 2010 Mar;28(3):452-8. doi: 10.1097/HJH.0b013e3283340c2b. PMID: 20087217.

ESH-IP:2002 - Pass General population