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Medisign MM1000
Device Model:
MM1000
Manufacturer:
Tianjin Empecs Medical Device Co. Ltd. (Medisign), 35 and 37 Yingcheng Street, Hangu, Binhai New Area, 300480 Tianjin, CHINA.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger and general Alternative Site Testing
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Medisign MM1000 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 normally taken from the finger but alternative site testing is allowed. It is intended for self-measurement and home use.
Assessment:
While the technology used in the Medisign MM1000, to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified.
Recommendations:
Accuracy AssessmentRecommendationBasis
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