Globalcare GCE603

Description:

The Globalcare GCE603 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.

Assessment:

The technology used in the Globalcare GCE603, 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	Stride BP	Self-measurement for adults (Preferred)	Published evidence

Device Family:

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

Validation Publications:

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

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