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A&D UA-1200CNBLE – 1200 UltraConnect

Device Name:LifeSource 1200 UltraConnect
Device Model:UA-1200CNBLE
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 both professional use and self-measurement
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the A&D UA-1200CNBLE - 1200 UltraConnect to measure blood pressure. However, this device appears to be very similar to a validated device by the same manufacturer but equivalence needs to be proven 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.
Hypertension CanadaSelf-measurement (Gold)Manufacturer declaration of equivalence

Device Family:A&D UA-1200BLEZ, A&D UA-1200CNBLE - 1200 UltraConnectZ (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.

A&D UA-1200BLE

Kario K, Saito K, Sato K, Hamasaki H, Suwa H, Okura A, Hoshide S. Validation of the A&D BP UA-1200BLE device for home blood pressure measurement according to the ISO 81060-2: 2013 standard. Blood Press Monit. 2018 Dec;23(6):312-314. Epub: 2018 Sep 7. doi: 10.1097/MBP.0000000000000347. PMID: 30199378.

81060-2:2013 - Pass General population