A&D UA-782
Device Model:
UA-782
Manufacturer:
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:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Australia and Ireland
Device Specifications:
Description:
The A&D UA-782 is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
While the technology used in the A&D UA-782, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
| BP | BIHS (UK and IRL) | Self-measurement | Manufacturer declaration of equivalence |
| BP | ESH (Europe) | Self-measurement | The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria. |
| Consumer Body | Year(s) | Level | Comment | |
| BP | Choice (Australia) | Previous: 2019 | A |
Device Family:
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-787
Longo D, Toffanin G, Garbelotto R, Zaetta V, Businaro L, Palatini P. Performance of the UA-787 oscillometric blood pressure monitor according to the European Society of Hypertension protocol. Blood Press Monit. 2003 Apr;8(2):91-5. PMID: 12819561.
ESH-IP:2002 - Pass General population