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Visomat Comfort Form (v1)

Device Name:Comfort Form
Device Model:24035

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

The technology used in the Visomat Comfort Form (v1), 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.

Accuracy AssessmentRecommendationBasis
MedavalLegacy approvalOlder clinical validation; older protocol
BIHS (UK and IRL)Used as seed device for derivative(s)
ESH (Europe)Self-measurementPublished evidence
Stride BPSelf-measurement for adults (Preferred)Published evidence

Device Family:Visomat ComfortB, Visomat Comfort Form (v1)B (B BIHS Derivative)
Validation Publications

Bonso E, Dorigatti F, Saladini F, Palatini P. Validation of the Visomat Comfort form device for home blood pressure measurement according to the International Protocol. Blood Press Monit. 2010 Feb;15(1):63-6. doi: 10.1097/MBP.0b013e32833531de. PMID: 20075716.

ESH-IP:2002 - Pass General population