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Unimedic Tensioday

Device Name:Tensioday
Manufacturer:

Brand: Unimedic Ltd. (Suspended), Kemp House, 160 City Road, London EC1V 2NX, UNITED KINGDOM.

Other: Tensiomed Ltd., Kétújfalu str. 163, H-1182 Budapest, HUNGARY.

Measuring functions:Blood pressure
Primary Client Use:Intended for ambulatory blood pressure monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Obsolete
Assessment:

While the technology used in the Unimedic Tensioday, to measure blood pressure, has been declared 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 the results of the assessment on which the declaration has been based have not been published either and cannot be verified. However, there are validation studies proving clinical validation of the same measurement technology, according to other equivalence claims.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)ABPMImplied equivalence to the Tensiomed Tensioday

Device Family:BTL BTL-08 ABPM (V2)Z, Tensiomed TensiodayB, Unimedic TensiodayB (B BIHS Derivative, 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.

Tensiomed Tensioday

Németh Z, Móczár K, Deák G. Evaluation of the Tensioday ambulatory blood pressure monitor according to the protocols of the British Hypertension Society and the Association for the Advancement of Medical Instrumentation. Blood Press Monit. 2002 Jun;7(3):191-7. PMID: 12131077.

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

SP10:2002 - Pass General population