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Meditech ABPM-05

Device Name:ABPM-05
Manufacturer:Sole: Meditech Ltd., Mikszath Kalman utca 24, 1184 Budapest, HUNGARY.
Measuring functions:Blood pressure
Primary Client Use:Intended for ambulatory blood pressure monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Intermittent measurements at specified intervals or times
Availability:Available Currently
Assessment:

The technology used in the Meditech ABPM-05, 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.
BIHS (UK and IRL)ABPMManufacturer declaration of equivalence
ESH (Europe)ABPMPublished evidence

Device Family:BIOS ABP-01Z, BTL Cardiopoint BTL-08 ABPM (V1)B, Meditech ABPM-04B,D, Meditech ABPM-05B,D, Meditech card(X)ploreD, Omron M24/7 (ABPM-BP5)B, VectraCor ABPM-05Z (B BIHS Derivative, D DET Equivalence, Z Almost Certain)
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.

Meditech ABPM-04

Barna I, Keszei A, Dunai A. Evaluation of Meditech ABPM-04 ambulatory blood pressure measuring device according to the British Hypertension Society protocol. Blood Press Monit. 1998;3(6):363-8. PMID: 10212378.

BHS:1993 - Pass (B/B) General population

SP10:1992 - Pass General population