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Hartmann Veroval Compact+ (BPU 26)
Device Name:
Veroval Compact+
Device Model:
BPU 26
Manufacturer:

OBL: Paul Hartmann AG, Paul-Hartmann-Straße 12, 89522 Heidenheim, GERMANY.

OEM: Globalcare Medical Technology Co. Ltd., Building 7, 39 Middle Industrial Main Road, Xiaolan Industrial Zone, Xiaolan Town, Zhongshan City, Guangdong 528415, CHINA.

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
Availability according to Countries or Regions:
Germany
Description:
The Hartmann Veroval Compact+ (BPU 26) 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 Hartmann Veroval Compact+ (BPU 26), 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 AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP DHL (DE) General use (Latest: 2023) Manufacturer declaration of equivalence
BP Stride BP Self-measurement for adults (Preferred) Equivalence to the Globalcare GCE603 claim without published evidence
Device Family:
Beurer BM 28P, Beurer BM 27P, Beurer BM 28 HSDZ, Beurer BM 53P, Globalcare GCE603P, Hartmann Veroval Compact+ (BPU 26)P
Legend: P Stride Equivalence, Z Almost Certain
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.

Beurer BM 28

Deutsch C, Bramlage C, Botta B, Krüger R, Forstner K, Bramlage P, Beime B. Validation of the blood pressure measurement device Beurer BM 28 according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2021 Aug 1;26(4):292-298. Epub: 2021 Mar 18. doi: 10.1097/MBP.0000000000000528. PMID: 33741775.

ESH-IP:2010 - Pass General population

Globalcare GCE603

Song C, Yu Y, Lu BC, Yan XL. Validation of the Globalcare GCE603 automated blood pressure monitor for self-measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2020 Oct;25(5):291-294. Epub: 2020 Jun 23. doi: doi: 10.1097/MBP.0000000000000461. PMID: 32898351.

ESH-IP:2010 - Pass General population

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