EPS EasyMax V2
Device Name:
EasyMax V2
Manufacturer:
Distributer: Oak Tree International Holdings lnc., Suite 253, 9550 South Eastern Ave., Las Vegas, NV 89123, UNITED STATES.
Other: EPS Bio Technology Corp., 8 R&D Road III, Hsinchu Science Park, Hsinchu 30077, TAIWAN ROC.
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 EPS EasyMax V2 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 EPS EasyMax V2, 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 | Institute of Health Economics (CA) | General use | No evidence provided |