Hartmann Veroval Compact (BPU 22) (V2)
Device Name:
Veroval Compact
Device Model:
BPU 22 (Note: 2 of 2)
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 22) (V2) 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:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Hartmann Veroval Compact (BPU 22) (V2) to measure blood pressure. However, this device appears to be very similar to a validated device by the same manufacturer or a device within a family of equivalent devices, but equivalence needs to be proven 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. |
| BP |
DHL (DE) |
General use (Latest: 2022) |
Manufacturer declaration of equivalence |
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.
AViTA BPM63S
Kang YY, Zeng WF, Liu M, Li Y, Wang JG. Validation of the AVITA BPM63S upper arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2014 Feb;19(1):46-9. doi: 10.1097/MBP.0000000000000014. PMID: 24322871.
ESH-IP:2010 - Pass General population
