Medisana BW 315 (51072)
Device Name:
BW 315
Device Model:
51072
Manufacturer:
OBL: Medisana AG, Jagenbergstraße 19, D-41468 Neuss, GERMANY.
OEM: Combei Technology Co. Ltd., Floor 3, Bldg. B, Jinxiongda Technology Park, 105 Huanguan South Road, Dahe Community, Guanlan Street, Bao'an, Shenzhen, Guangdong 518110, CHINA.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Device Manual:
Description:
The Medisana BW 315 (51072) 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 wrist. It is intended for self-measurement and home use.
Assessment:
While the technology used in the Medisana BW 315 (51072), to measure blood pressure, has been declared, on the manufacturer website, as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | Not recommended | This device has not been shown to have been clinically validated. |
| Consumer Body | Year(s) | Level | Comment | |
| BP | Stiftung Warentest (DE) | Previous: 2018 | Adequate | This review must not be considered as a substitute for a proper peer-reviewed scientific assessment |
Device Family:
Combei BP606WY, Juning BP606WZ, Medisana BW 315 (51072)Y, OxiPro BP1Y, Yonker YK-BPA2 (V3)Y
Legend: Y Internal declaration, Z Almost Certain
Legend: Y Internal declaration, Z Almost Certain