Visgeneer eBchek (eB-S01)

Device Name:

eBchek

Device Model:

eB-S01

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 eBchek (eB-S01) 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 eBchek (eB-S01), 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