|BP||Medaval||None||Although equivalence to another device is claimed, this has not been tested to MDR requirements.|
|BP||Stride BP||Self-measurement for adults||Equivalence claim without published evidence|
Legend: P Stride Equivalence, Y Internal declaration
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.
Saito K, Hishiki Y, Takahashi H. Validation of two automatic devices, Omron HEM-6232T and HEM-6181, for self-measurement of blood pressure at the wrist according to the ANSI/AAMI/ISO 81060-2:2013 protocol and the European Society of Hypertension International Protocol revision 2010. Vasc Health Risk Manag. 2019 Mar 6;15:47-55. doi: 10.2147/VHRM.S188089. PMID: 30881007. Available from: PMC6410757. eCollection 2019. Erratum in: Vasc Health Risk Manag. 2019 May 17;15:137.
81060-2:2013 - Pass General population
ESH-IP:2010 - Pass General population
The studies use the same data and are, therefore, not independent.