Medel Replay

Device Name:

Replay

Manufacturer:

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

OBL: Beurer GmbH, Söflinger Straße 218, 89077 Ulm, GERMANY.

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

Availability:

Obsolete

Description:

The Medel Replay is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use. This device is now obsolete.

Assessment:

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.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.

Device Family:

Medel ReplayD, SensaCare SAW-102D
Legend: 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