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Honsun Scian LD-528

Device Name:Scian
Device Model:LD-528
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:

While the technology used in the Honsun Scian LD-528, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Self-measurementManufacturer declaration of equivalence
ESH (Europe)Self-measurementThe BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.

Validation Publications for Equivalent Devices

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Honsun Scian LD-578

Zhang Y, Wang J, Huang QF, Sheng CS, Li Y, Wang JG. Validation of the HONSUN LD-578 blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol. Blood Press Monit. 2009 Jun;14(3):128-31. doi: 10.1097/MBP.0b013e32832ce149. PMID: 19454866.

ESH-IP:2002 - Pass General population