Omron HBP-T105S-N
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 Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. | ||
| Japanese Society of Hypertension | Professional use (2016-2018) | Implied equivalence to the Omron HBP-T105, Pic Solution Professional Check, BP10 | ||
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
