Hartmann Veroval Compact (BPU 22) (V1)

Device Name:

Veroval Compact

Device Model:

BPU 22, GCE606 (Note: 1 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) (V1) 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 22) (V1), 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	DHL (DE)	General use (Previous: 2018)	Manufacturer declaration of equivalence
BP	Stride BP	Self-measurement for adults (Preferred)	Equivalence to the Globalcare GCE603 claim without published evidence

	Consumer Body	Year(s)	Level	Comment
BP	Stiftung Warentest (DE)	Latest: 2020	Good

Device Family:

AViTA BPM63SP, AViTA BPM65P, Hartmann Veroval Compact (BPU 22) (V1)P, Hartmann Veroval Compact (BPU 22) (V2)Z
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.

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