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Medel Idea (91913)

Device Name:Idea
Device Model:91913
Manufacturer:

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

OEM: SensaCare Ltd., Unit 803, 9 Wing Hong Street, Cheung Sha Wan, Kowloon, 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:Discontinued but still available
Assessment:

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.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
ESH (Europe)Self-measurementPublished evidence

Device Family:Medel Idea (91913)D, SensaCare SAA-102D (D DET Equivalence)
Validation Publications for Equivalent Devices

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.

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