Beurer BM 28 - Medaval

Description:

The Beurer BM 28 is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.

Assessment:

The technology used in the Beurer BM 28, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	★★ Recommendation	Recent clinical validation; recent protocol
BP	BIHS (UK and IRL)	Self-measurement	Published evidence
BP	DHL (DE)	General use (2016,2023)	Manufacturer declaration of equivalence
BP	Stride BP	Self-measurement for adults (Preferred)	Published evidence plus equivalence claim

	Consumer Body	Year(s)	Level	Comment
BP	Stiftung Warentest (DE)	Previous: 2018	Satisfactory

Device Family:

Beurer BM 28P, Beurer BM 27P, Beurer BM 28 HSDZ, Globalcare GCE603P
Legend: P Stride Equivalence, Z Almost Certain

Validation Publications:

Deutsch C, Bramlage C, Botta B, Krüger R, Forstner K, Bramlage P, Beime B. Validation of the blood pressure measurement device Beurer BM 28 according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2021 Aug 1;26(4):292-298. Epub: 2021 Mar 18. doi: 10.1097/MBP.0000000000000528. PMID: 33741775.

ESH-IP:2010 - Pass General population

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.

Globalcare GCE603

Song C, Yu Y, Lu BC, Yan XL. Validation of the Globalcare GCE603 automated blood pressure monitor for self-measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2020 Oct;25(5):291-294. Epub: 2020 Jun 23. doi: doi: 10.1097/MBP.0000000000000461. PMID: 32898351.

ESH-IP:2010 - Pass General population