Visgeneer eBcarryon (eB-A)
Device Name:
eBcarryon
Device Model:
eB-A
Manufacturer:
Visgeneer Inc., No. 335 Sec. 6, Zhonghua Rd., Xiangshan Dist., Hsinchu City 30094, TAIWAN ROC.
Measuring functions:
Blood glucose, β-Ketones
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Visgeneer eBcarryon (eB-A) 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 Visgeneer eBcarryon (eB-A), 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 |