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

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

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
Assessment:

While the technology used in the BIOS Precision 10.0 (3MS1-4K) aka Ultra BD350, 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 has not been clinically validated. Although equivalence to another device is claimed by the manufacturer, this has not been tested scientifically.
Hypertension CanadaGeneral useManufacturer declaration of equivalence