While the technology used in the Duronic BPM-300, 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.
|Medaval||None||Although equivalence to another device is claimed, this has not been tested to MDR requirements.|
|BIHS (UK and IRL)||Self-measurement||Manufacturer declaration of equivalence|
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.
Tian HY, Liu WJ, Li SG, Song Z, Gong W. Validation of the TRANSTEK TMB-988 wrist blood pressure monitor for home blood pressure monitoring according to the International protocol. Blood Press Monit. 2010 Dec;15(6):326-8. doi: 10.1097/MBP.0b013e32833f56fb. PMID: 20827174.
ESH-IP:2002 - Pass General population