Medel idea

Device Name:Idea

OBL: Medel Group S.p.A., Via Micheli 9, 43056 San Polo di Torrile, (Parma), ITALY.

OEM: Sensacare Ltd., 11/F AXA Centre, 151 Gloucester Rd., Wanchai, HONG KONG PRC.

Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment: The technology used in the Medel idea, to measure blood pressure, has been compared to a validated device but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Device Family:SensaCare SAA-102D (D DET Equivalence)
Validation Publications for Equivalent Devices

Note: Provisional list; equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) not proven

SensaCare SAA-102

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