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Microlife BP B1 Classic

Device Name:BP B1 Classic
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:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Description: The Microlife BP B1 Classic is an automatic blood pressure monitor. Claims for validation are being verified by Medaval. Measurements are taken from the upper arm and it is intended for self-measurement and home use.
Assessment:

The Microlife BP B1 Classic is included in a current validation and equivalence audit, by Medaval, in preparation for (EU) 2017/745. Validation details will be posted when this has been completed.

Accuracy AssessmentRecommendationBasis
MedavalAuditValidation under audit
Stride BPSelf-measurement for adults (Preferred)Equivalence claim without published evidence

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 B3 AFib (BP 3KT1-3N)

Beime B, Bramlage C, Kr├╝ger R, Deutsch C, van Mark G, Bramlage P, Botta B. Validation of the Microlife BP B3 AFIB upper arm blood pressure monitor in adults and adolescents according to the ANSI/AAMI/ISO 81060-2: 2019 protocol. Blood Press Monit. 2021 Aug 1;26(4):299-304. Epub: 2021 Mar 15. doi: 10.1097/MBP.0000000000000530. PMID: 33734119.

81060-2:2019 - Pass General population