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Fora Premium V12 (TD-4125)

Device Name:Fora Premium
Device Model:V12, TD-4125
Manufacturer:ForaCare Suisse AG, Neugasse 55, CH-9000 St. Gallen, SWITZERLAND.
Measuring functions:Blood glucose
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Finger and general Alternative Site Testing
Measurement Occurrence:Single measurements only
Device Accessibility:Voiced instructions and results
Availability:Discontinued but still available
Description: The Fora Premium V12 (TD-4125) is a clinically validated blood glucose meter. Measurements are normally taken from the finger but alternative site testing is allowed and it is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:

While the technology used in the Fora Premium V12 (TD-4125), to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified. It also appears to be very similar to another device by the same manufacturer but equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
Institute of Health Economics (CA)General useNo evidence provided

Device Family:Fora Premium V12 (TD-4125)Z, Fora Premium Voice V12 (TD-4125)Z (Z Almost Certain)