Microlife BP B3 Basic (BP 3KT1-3F)
The Microlife BP B3 Basic (BP 3KT1-3F) 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.
|Medaval||Audit||Validation under audit|
|Stride BP||Self-measurement for adults (Preferred)||Equivalence claim without published evidence|
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, Krüger 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