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Microlife BP A200 Comfort (BP 3MS1-4A)
Device Name:
BP A200 Comfort
Device Model:
BP 3MS1-4A
Manufacturer:
Microlife Corporation, 9F - 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN ROC.
Measuring functions:
Blood pressure
Primary Client Use:
Developed as a research version only - Never sold commercially
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Not made available
Description:
The Microlife BP A200 Comfort (BP 3MS1-4A) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a certified 5-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for use only as a reasearch version.
Assessment:
The accuracy of the technology used in the Microlife BP A200 Comfort (BP 3MS1-4A), to measure blood pressure, is certified by Medaval Ltd. It has passed in two clinical validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval ★★★★★ Certified Accuracy Recent clinical validation; recent protocol with certified adherence; multiple clinical validations
BP BIHS (UK and IRL) Self-measurement Published evidence
BP ESH (Europe) Self-measurement Published evidence
BP Stride BP Self-measurement for adults Published evidence
BP FDA (US) 510(k) 510(k) K153450
BP MDR Criteria Self-measurement Published evidence
Device Family:
Microlife BP A200 (BP 3MS1-4K)B, Microlife BP A200 Comfort (BP 3MS1-4A)B,P, Microlife BP A3L Comfort (BP 3GX1-3A, A3L-IMT)P
Legend: B BIHS Derivative, P Stride Equivalence
Validation Publications:

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

Medaval Certification Assessment

Certification ImageMedaval Ltd. Accreditation assessment of the blood pressure measurement technology used in the Microlife BP A200 Comfort (BP3MS1-4A) upper arm monitor, as validated according to the European Society of Hypertension International Protocol revision 2010 and also the AAMI/ANSI/ISO 81060-2:2013 standard for a general study in adults. Medical Device Assessment. 2016 Aug 5;2016(1605) 8 p. Epub: 2019 Jan 31. Available from: www.medaval.ie.

With proven validity of validation results according to an accepted protocol, the clinical accuracy of the blood pressure measurement technology, used in the Microlife BP A200 Comfort, is certified by Medaval Ltd.