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Microlife WatchBP Home N (BP 3MX1-4)

Device Name:WatchBP Home N
Device Model:BP 3MX1-4
Manufacturer:Sole: 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 and repeated measurements
Availability:Discontinued but still available

The technology used in the Microlife WatchBP Home N (BP 3MX1-4), to measure blood pressure, has been compared to a clinically validated device but not 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.
ESH (Europe)Self-measurementPublished evidence

Device Family:Microlife WatchBP Home (BP 3MX1-1)D,P, Microlife WatchBP Home A (BP 3MX1-3)D,P, Microlife WatchBP Home A BT (BP 3MX1-3C)P, Microlife WatchBP Home N (BP 3MX1-4)D, Microlife WatchBP Home S (BP 3MX1-5)P (D DET Equivalence, P Stride Equivalence)
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.

Microlife WatchBP Home (BP 3MX1-1)

Stergiou GS, Giovas PP, Gkinos CP, Patouras JD. Validation of the Microlife WatchBP Home device for self home blood pressure measurement according to the International Protocol. Blood Press Monit. 2007 Jun;12(3):185-8. PMID: 17496469.

ESH-IP:2002 - Pass General population

Chung Y, de Greeff A, Shennan A. Validation and compliance of a home monitoring device in pregnancy: Microlife WatchBP home. Hypertens Pregnancy. 2009;28(3):348-59. doi: 10.1080/10641950802601286. PMID: 19263287.

BHS:1993 Pregnancy and pre-eclampsia (n=45; 15 pre-eclampsia) (Note: BHS results not in abstract)

Clark K, Snowball O, Nzelu D, Kay P, Kametas NA. Validation of the Microlife WatchBP Home blood pressure device in pregnancy for medium and large arm circumferences. Blood Press Monit. 2018 Jun;23(3):171-4. doi: 10.1097/MBP.0000000000000315. PMID: 29596069.

BHS:1993 - Pass (A/A) Pregnancy; Arm circumference 22 cm to 31 cm (n=51)

BHS:1993 - Pass (B/A) Pregnancy; Arm circumference 32 cm to 52 cm (n=46)