B.Well PRO-35
Device Model:
PRO-35
Manufacturer:
B.Well Swiss AG, Bahnhofstrasse 24, 9443 Widnau, SWITZERLAND.
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
Description:
The B.Well PRO-35 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 B.Well PRO-35, 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 | Stride BP | Self-measurement and professional use for adults (Preferred) | Equivalence to the B.Well PRO-33 claim without published evidence |
Device Family:
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.
B.Well PRO-33
Posnenkova O, Simonyan M, Akimova N. Validation of B.Well PRO-33 oscillometric blood pressure monitor for professional office use in the general population in accordance with Amendment 2 of the Standard 81060-2:2018 by the International Organization for Standardization (ISO 81060-2:2018/AMD 2:2024). Blood Press Monit. 2026 Apr 1;31(2):90-94. Epub: 2025 Nov 13. doi: 10.1097/MBP.0000000000000785. PMID: 41230734.
81060-2:2018/Amd 1:2020/Amd 2:2024 - Pass General population