While the technology used in the A&D TM-2657, 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.
|Medaval||None||Although equivalence to another device is claimed, this has not been tested to MDR requirements.|
|Japanese Society of Hypertension||Professional use (2019)||Non-compliant equivalence to the A&D TM-2656|
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.
Zeng WF, Liu M, Kang YY, Li Y, Wang JG. Validation of the fully automated A&D TM-2656 blood pressure monitor according to the British Hypertension Society Protocol. Blood Press Monit. 2013 Aug;18(4):223-6. doi: 10.1097/MBP.0b013e3283624abd. PMID: 23681206.
BHS:1993 - Pass (A/A) General population