Fora Premium V10 (TD-4124)
While the technology used in the Fora Premium V10 (TD-4124), 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.
|Medaval||None||Although equivalence to another device is claimed, this has not been tested to MDR requirements.|
|Institute of Health Economics (CA)||General use||No evidence provided|