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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:

While the technology used in the Omron HBP-T105S-N, to measure blood pressure, has been claimed as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but there is no evidence provided on a validation of the other device.

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