Pempa BP100
Device Name:
BP100
Manufacturer:
OBL: Pempa Jerzy Żukowski sp. jawna (Pempa), Biesiadna 7, 35-304 Rzeszów, POLAND.
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
Description:
The Pempa BP100 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 Pempa BP100, 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 | Equivalence to the Combei BP118A claim without published evidence |
Device Family:
Combei BP118AP, Pempa BP100P, Pempa BP80P, Prolife PA5-Comfort (BP136A)P
Legend: P Stride Equivalence
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.
Combei BP118A
Tasić N, Topouchian J, Tasic D, Kovacevic Z, Filipovic M, Asmar R. Accuracy of the COMBEI BP118A Device for Self-Blood Pressure Measurements in General Population - Validation According to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard. Vasc Health Risk Manag. 2022 Mar 12;18:123-129. doi: 10.2147/VHRM.S353715. PMID: 35309162. Available from: PMC8926011.
81060-2:2019 - Pass General population