GreenCross CeraChek 1070 (G-300)
Device Name:
CeraChek 1070
Device Model:
G-300
Manufacturer:
GreenCross Medical Science Corp. (Formerly Ceragem Medisys Inc.), 107 Ihyeon-ro 30beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do (Bojeong-dong), REPUBLIC of KOREA.
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 GreenCross CeraChek 1070 (G-300) 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 GreenCross CeraChek 1070 (G-300), 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| BG | TÜV SÜD (DE) | General use | Unpublished internal data |