Beurer BM 28 HSD

Description:

The Beurer BM 28 HSD is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.

Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Beurer BM 28 HSD to measure blood pressure. However, this device appears to be very similar to a validated device by the same manufacturer, but equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.

Device Family:

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

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.

Beurer BM 28

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

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