Microlife BP W100 (BP 3MK1-3)

Device Name:BP W100
Device Model:BP 3MK1-3
Manufacturer:Sole: Microlife Corporation, 9F, 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN PRC.
Measuring functions:Blood pressure, Arrhythmias
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 Microlife BP W100 (BP 3MK1-3), to measure blood pressure, has passed in three validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.

*** Claim not defined ***

Device Family:Braun Vitalscan 1 (BBP-2000)D (D DET Equivalence)
Validation Publications

Palatini P, Dorigatti F, Bonso E, Ragazzo F. Validation of Microlife BP W100 wrist device assessed according to the European Society of Hypertension and the British Hypertension Society protocols. Blood Press Monit. 2009 Feb;14(1):41-4. doi: 10.1097/MBP.0b013e32831e30d2. PMID: 19252436.

ESH-IP:2002 - Pass General population

Tholl U, Lüders S, Bramlage P, Dechend R, Eckert S, Mengden T, Nürnberger J, Sanner B, Anlauf M. The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices: 15-year experience and results from 105 devices for home blood pressure control. Blood Press Monit. 2016 Aug;22(4):197-205. doi: 10.1097/MBP.0000000000000186. PMID: 26998590.

DHL:1999 - Pass General population (Note: 2007)

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

Braun Vitalscan 1 (BBP-2000)

Wessig K, Hollinger S, Schmalzhaf I, Lenz T. Clinical evaluation of the efficacy of the Braun PrecisionSensor oscillometric wrist blood pressure monitor for use on adults versus auscultation as defined by ANSI/AAMI SP10-1992. Blood Press Monit. 2000 Aug;5(4):239-45. PMID: 11035867.

SP10:1992 - Pass General population