Medel Sense (95251)
Device Name:
Sense
Device Model:
95251
Manufacturer:
Brand: Medel Group S.p.A., Via Micheli 9, 43056 San Polo di Torrile (Parma), ITALY.
OBL: Beurer GmbH, Söflinger Straße 218, 89077 Ulm, GERMANY.
Measuring functions:
Blood Pressure and PR
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:
Device Specifications:
Description:
The Medel Sense (95251) is an automatic blood pressure monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Medel Sense (95251) to measure blood pressure.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | Not recommended | This device has not been clinically validated. |
| BP | DHL (DE) | General use (Latest: 2023) | Manufacturer declaration of equivalence |