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A&D UB-512H

Device Model:UB-512H
Manufacturer:Sole: A&D Company Ltd., 3-23-14 Higashi-Ikebukuro, Toshima-Ku, 170-0013 Tokyo, JAPAN.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Wrist
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

While the technology used in the A&D UB-512H, to measure blood pressure, has been claimed 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 there is no evidence provided on a validation of the other device.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
Japanese Society of HypertensionSelf-measurement (2018)Implied equivalence to the A&D UB-511 or UB-512

Device Family:A&D UB-510J, A&D UB-511J, A&D UB-511LJ, A&D UB-512J, A&D UB-512HJ (J JHS Implied 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.

A&D UB-511

Angeli F, Sardone M, Angeli E, Repaci S, Gattobigio R, Verdecchia P. Validation of the A&D wrist-cuff UB-511 (UB-512) device for self-measurement of blood pressure. Blood Press Monit. 2006 Dec;11(6):349-54. PMID: 17106320.

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

A&D UB-512

Angeli F, Sardone M, Angeli E, Repaci S, Gattobigio R, Verdecchia P. Validation of the A&D wrist-cuff UB-511 (UB-512) device for self-measurement of blood pressure. Blood Press Monit. 2006 Dec;11(6):349-54. PMID: 17106320.

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