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Fia Biomed Precisa
Device Name:
Precisa
Manufacturer:
Fia Biomed GmbH, Rheiner Straße 172, D-48282 Emsdetten, GERMANY.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Fia Biomed Precisa is an automatic blood glucose meter. The accuracy of its blood glucose measurement technology has yet to be proven to MDR requirements. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
While the technology used in the Fia Biomed Precisa, to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval None While a clinical validation is claimed, it cannot be checked properly.
BG TÜV Rheinland Nederland General use Unpublished internal data