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BIOS BD350 aka 3MS1-4K aka Ultra (Precision 10.0)

Device Name:Precision 10.0 and Ultra
Device Model:BD350 and 3MS1-4K

OBL: BIOS Medical, 16975 Leslie Street, Newmarket, Ontario L3Y 9A1, CANADA.

OEM: Microlife Corporation, 9F - 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN PRC.

Measuring functions:Blood pressure, Atrial fibrillation
Primary Client Use:Intended for self-measurement and home use with atrial fibrillation detection
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently

While the technology used in the BIOS BD350 aka 3MS1-4K aka Ultra (Precision 10.0), 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
MedavalNot recommendedThis device failed clinical validation.
Hypertension CanadaSelf-measurement (Gold)Manufacturer declaration of equivalence