Visomat Double Comfort (24056) (v2)
Device Name:
Double Comfort
Device Model:
24056
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
Description:
The Visomat Double Comfort (24056) (v2) 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:
The technology used in the Visomat Double Comfort (24056) (v2), to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP Stride BP Self-measurement for adults Equivalence claim without published evidence
Device Family:
Visomat Comfort E (24016) (v2)D, Visomat Double Comfort (24050) (v1)D,P, Visomat Double Comfort (24056) (v2)P
Legend: D DET Equivalence, P Stride Equivalence
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.

Visomat Double Comfort (24050) (v1)

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).

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