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Mindray BeneVision N12

Device Name:BeneVision N12
Manufacturer:Shenzhen Mindray Bio-Medical Electronics Co. Ltd., Mindray Building, Keji 12th Road South, High-tech Industrial Park, Nanshan, Shenzhen 518057, CHINA.
Measuring functions:Blood pressure, Arrhythmias, SpO2, Temperature, ECG, Respiration
Primary Client Use:Intended for patient monitoring
Measurement Site:Arm and Intra-Arterial
Measurement Occurrence:Continuous and intermittent measurements
Availability:Available Currently

While the technology used in the Mindray BeneVision N12, to measure blood pressure, has been declared as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but the results of the assessment on which the declaration has been based have not been published either and cannot be verified. However, there are validation studies proving clinical validation of the same measurement technology, according to other equivalence claims.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Hospital useManufacturer declaration of equivalence to a device without published evidence

Device Family:Datascope iPM 12B, Mindray Beneview T5B, Mindray BeneVision N12B, Mindray iMEC-12B (B BIHS Derivative)