Omron HBP-T105S-N
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 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
