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Gima Domino (32803)

Device Name:Domino
Device Model:32803
Manufacturer:Gima S.p.A., Via Marconi 1, 20060 Gessate Milano, ITALY.
Measuring functions:Blood pressure
Primary Client Use:Intended for professional use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Description: The Gima Domino (32803) is a non-clinically-validated automatic desk (tabletop) or wall-mounted blood pressure monitor. Measurements are taken from the upper arm and it is intended for professional use.
Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Gima Domino (32803) to measure blood pressure. However, this device appears to be very similar to another device by the same manufacturer. At least one validation needs to be published and equivalence needs to be proven according to protocols compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device has not shown to have been clinically validated.

Device Family:Gima Domino (32803)Z, Gima Domino (Trolly) (32804)Z (Z Almost Certain)