Medel Replay

Device Name:Replay
Manufacturer:

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:Wrist
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment: The technology used in the Medel Replay, to measure blood pressure, has passed in a validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Device Family:SensaCare SAW-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 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