Braun ExactFit 1 (BUA-5000)

Device Name:ExactFit 1
Device Model:BUA-5000
Manufacturer:

OBL: B. Braun Melsungen AG, Carl-Braun-Stra├če, 134212 Melsungen, GERMANY.

OEM: Microlife Corporation, 9F, 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN PRC.

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
Assessment: The technology used in the Braun ExactFit 1 (BUA-5000), to measure blood pressure, has been compared to a validated device but the results of the 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.