Home /  Medel Replay

Medel Replay

Device Name:Replay

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:Wrist
Measurement Occurrence:Single measurements only
Description: The Medel Replay is a clinically validated automatic blood pressure monitor. Measurements are taken from the wrist and it is intended for self-measurement and home use. This device is now obsolete.

The technology used in the Medel Replay, 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.

Device Family:Medel ReplayD, SensaCare SAW-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 SAW-102

Zaetta V, Longo D, Perkovic D, Perfetti P, Gabrieli A, Pratticò F, Winnicki M. Validation of the SAW-102 wrist home blood pressure monitor according to the protocols of the British Hypertension Society, the Association for the Advancement of Medical Instrumentation, and the European Society of Hypertension. Blood Press Monit. 2009 Feb;14(1):32-6. doi: 10.1097/MBP.0b013e3283105496. PMID: 19262198.

ESH-IP:2002 - Pass General population

BHS:1993 - Pass (B/B) General population

SP10:1996 - Pass General population