Visomat Comfort 20-40 (24046) (v3)
Device Name:
Comfort 20-40
Device Model:
24046
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
Availability according to Countries or Regions:
Germany
Device Manual:
Description:
The Visomat Comfort 20-40 (24046) (v3) 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 Comfort 20-40 (24046) (v3), 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 Assessment | Recommendation | Basis | |
| BP | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
| BP | DHL (DE) | General use (2017) | Manufacturer declaration of equivalence |
| BP | Stride BP | Self-measurement for adults | Equivalence claim without published evidence |
| Consumer Body | Year(s) | Level | Comment | |
| BP | Stiftung Warentest (DE) | Latest: 2020 | Satisfactory |
Device Family:
Visomat Comfort 20-40 (24040) (v2)P, Visomat Comfort 20-40 (24046) (v3)P
Legend: P Stride Equivalence
Legend: 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 Comfort 20-40 (24040) (v2)
Stergiou GS, Tzamouranis D, Nasothimiou EG, Protogerou AD. Can an electronic device with a single cuff be accurate in a wide range of arm size? Validation of the Visomat Comfort 20/40 device for home blood pressure monitoring. J Hum Hypertens. 2008 Nov;22(11):796-800. Epub: 2008 Jul 3. doi: 10.1038/jhh.2008.70. PMID: 18596720.
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