Medel Idea (91913)
The technology used in the Medel Idea (91913), to measure blood pressure, has been compared to a clinically validated device but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
|Medaval||None||Although equivalence to another device is claimed, this has not been tested to MDR requirements.|
|ESH (Europe)||Self-measurement||Published evidence|
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.
Zaetta V, Daniele L, Perkovic D, Pratticò F, Barisa M, Perfetti P, Gabrieli A, Buonocore F, Winnicki M. Validation of the SAA-102 home blood pressure monitor according to the protocols of the European Society of Hypertension, the Association for the Advancement of Medical Instrumentation and the British Society of Hypertension. Blood Press Monit. 2007 Dec;12(6):363-8. PMID: 18004104.
ESH-IP:2002 - Pass General population
BHS:1993 - Pass (A/A) General population
SP10:1996 - Pass General population