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Microlife BP W3 Comfort (BP 3KB1-3E)

Device Name:BP W3 Comfort
Device Model:BP 3KB1-3E
Manufacturer:Sole: Microlife Corporation, 9F - 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN 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
Description: The Microlife BP W3 Comfort (BP 3KB1-3E) is a clinically validated automatic blood pressure monitor. Measurements are taken from the wrist and it is intended for self-measurement and home use.
Assessment:

The technology used in the Microlife BP W3 Comfort (BP 3KB1-3E), to measure blood pressure, has been compared to a clinically validated device but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance 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.
Stride BPSelf-measurement for adultsEquivalence claim without published evidence

Device Family:Aponorm Mobil Slim 3GP, Microlife BP W2 SlimP, Microlife BP W3 Comfort (BP 3KB1-3E)P (P Stride 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.

Microlife BP W2 Slim

Bing S, Chen K, Hou H, Zhang W, Li L, Wei J, Shu C, Wan Y. Validation of the Microlife BP A200 Comfort and W2 Slim automated blood pressure monitors in a general adult population according to the European Society of Hypertension and the ANSI/AAMI/ISO 81060-2: 2013 protocols. Blood Press Monit. 2016 Apr;21(2):118-23. Epub: 2015 Dec. doi: 10.1097/MBP.0000000000000169. PMID: 26683381.

ESH-IP:2010 - Pass General population

81060-2:2013 - Pass General population