Fora iDiamond (DM40)
Device Name:
Fora iDiamond
Device Model:
DM40
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
Measurement Occurrence:
Single measurements only
Availability:
Discontinued but still available
Device Manual:
Description:
The Fora iDiamond (DM40) 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. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
While the technology used in the Fora iDiamond (DM40), to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | None | While a clinical validation is claimed, it cannot be checked properly. |
| BG | TÜV Rheinland Nederland | General use | Unpublished internal data |