Visomat Double Comfort

Device Name:Double Comfort
Device Model:24050
Manufacturer:

OBL: Visomat, Zum Ottersberg 8-9, 97877 Wertheim am Main, GERMANY.

OEM: UEBE Medical GmbH, Zum Ottersberg 8-9, 97877 Wertheim am Main, GERMANY.

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
Assessment: The technology used in the Visomat Double Comfort, to measure blood pressure, is certified by Medaval Ltd. It has passed in two validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.
Device Family:Visomat Comfort E (v2)D (D DET Equivalence)
Validation Publications

Masiero S, Fania C, Palatini P. Validation of the UEBE Visomat Double Comfort upper arm blood pressure monitor, in auscultation mode, for clinic use and self-measurement in a general population, according to the European Society of Hypertension International Protocol, revision 2010. Blood Press Monit. 2011 Aug;16(4):208-10. doi: 10.1097/MBP.0b013e328348b6a0. (Details from: journals.lww.com/bpmonitoring/Abstract/2011/08000/Validation_of_the_UEBE_Visomat_Double_Comfort.9.aspx).

ESH-IP:2010 - Pass In auscultatory mode

Masiero S, Fania C, Palatini P. Validation of the UEBE Visomat Double Comfort upper arm blood pressure monitor, in oscillometric mode, for clinic use and self-measurement in a general population according to the European Society of Hypertension International Protocol, revision 2010. Blood Press Monit. 2011 Oct;16(5):262-4. doi: 10.1097/MBP.0b013e32834b6694. PMID: 21885959.

ESH-IP:2010 - Pass In Oscillometric mode

Medaval Certification Assessment

Medaval Ltd. Accreditation assessment of the blood pressure measurement technology used in the UEBE Visomat Double Comfort upper arm monitor, as validated according to the European Society of Hypertension International Protocol revision 2010. Medical Device Assessment. Epub: 2016 Aug 5(9):4 p.

The blood pressure measurement technology, used in the Visomat Double Comfort, is certified by Medaval Ltd.