Home /  Visomat Double Comfort (v1)

Visomat Double Comfort (v1)

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:Discontinued but still available
Description: The Visomat Double Comfort (v1) is a clinically validated and certified 5-star automatic blood pressure monitor. Measurements are taken from the upper arm and 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 accuracy of the technology used in the Visomat Double Comfort (v1), to measure blood pressure, is certified by Medaval Ltd. It has passed in validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.

Accuracy AssessmentRecommendationBasis
Medaval★★★★★ Certified AccuracyRecent clinical validation; recent protocol with certified adherence; multiple clinical validations
BIHS (UK and IRL)Self-measurementPublished evidence
ESH (Europe)Self-measurementPublished evidence
Stride BPSelf-measurement for adults (Preferred)Published evidence
 
Consumer BodyVersionQuartileComment
Stiftung Warentest (DE)Previous: 2018Satisfactory 

Device Family:Visomat Comfort E (v2)D, Visomat Double Comfort (v1)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

Cert ImageMedaval 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. 2016 Aug 5;2016(1609) 4 p. Epub: 2019 Jan 31. Available from: https://www.medaval.ie/MDA/2016/MDA1609.pdf.

With proven validity of validation results according to an accepted protocol, the clinical accuracy of the blood pressure measurement technology, used in the Visomat Double Comfort, is certified by Medaval Ltd.