Braun BPW-4100
Device Model:
BPW-4100
Manufacturer:
B. Braun Melsungen AG, Carl-Braun-Straße, 134212 Melsungen, GERMANY.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Discontinued but still available
Description:
The Braun BPW-4100 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 wrist. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
The technology used in the Braun BPW-4100, to measure blood pressure, has been compared to a clinically validated device, but not according to a protocol compliant 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. |
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.
Kingyield BP-210
Zeng WF, Huang QF, Sheng CS, Li Y, Wang JG. Validation of the Kingyield BP210 wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension-International Protocol. Blood Press Monit. 2012 Feb;17(1):42-4. doi: 10.1097/MBP.0b013e32834f8301. PMID: 22185959.
ESH-IP:2002 - Pass General population