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Honsun Scian LD-518

Device Name:Scian
Device Model:LD-518
Manufacturer:Sole: Shanghai Honsun International Trade Co. Ltd., Room C. Floor 22, Zhiyuan Building, 768 Xietu Road, Shanghai 200023, CHINA.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Honsun Scian LD-518 to measure blood pressure. However, this device appears to be very similar to another device by the same manufacturer. At least one validation needs to be published and equivalence needs to be proven according to protocols compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
Medaval

Device Family:Honsun Scian LD-518Z, Timesco Digital (D05.180)Z (Z Almost Certain)