Braun BUA4050 - Medaval

Description:

The Braun BUA4050 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 Braun BUA4050, 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 for adults (Preferred)	Equivalence to the BUA4000 claim without published evidence

Device Family:

Braun BUA4000P, Braun BUA4050P
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.

Braun BUA4000

Ntousopoulos V, Ntineri A, Theodosiadi A, Stathopoulou P, Menti A, Kyriakoulis KG, Kollias A, Stergiou GS. Validation of the oscillometric home blood pressure monitor Braun BUA4000 with wide-range cuff in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard. Blood Press Monit. 2024 Apr 1;29(2):99-102. Epub: 2023 Nov 15. doi: 10.1097/MBP.0000000000000684. PMID: 37997431.

81060-2:2020 - Pass General population