VivaChek Eco (VGM02)
Device Name:
Eco
Device Model:
VGM02
Manufacturer:
Distributer: VivaChek Laboratories Inc., Suite 200, 913 N Market Street, Wilmington, DE 19801, UNITED STATES.
Other: VivaChek Biotech (Hangzhou) Co. Ltd., Level 2, Block 2, 146 East Chaofeng Road, 311100 Hangzhou, CHINA.
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 VivaChek Eco (VGM02) 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 VivaChek Eco (VGM02), 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| BG | TÜV Rheinland Nederland | General use | Unpublished internal data |