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Hartmann Veroval GCE604

Device Name:Veroval GCE604
Manufacturer:Paul Hartmann AG, Paul-Hartmann-Stra├če 12, 89522 Heidenheim, GERMANY.
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
Assessment:

While the technology used in the Hartmann Veroval GCE604, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device failed clinical validation.
DHL (DE)General useManufacturer declaration of equivalence