Omron MIT Elite (HEM-7300-WE)
While the technology used in the Omron MIT Elite (HEM-7300-WE), 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.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. | ||
| BIHS (UK and IRL) | Previous recommendation, now archived | Manufacturer declaration of equivalence | ||
| ESH (Europe) | Self-measurement | Published evidence | ||
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.
Omron Elite 7300W (HEM-7300-EZ)
Grim CE, Grim CM. The Omron Elite 7300W home blood pressure monitor passes the European Society of Hypertension International Validation Protocol for women and men. Blood Press Monit. 2009 Apr;14(2):87-90. doi: 10.1097/MBP.0b013e328329d294. PMID: 19305188.
ESH-IP:2002 - Pass General population
Omron MIT Elite Plus (HEM-7301-ITKE7)
Tholl U, Lüders S, Bramlage P, Dechend R, Eckert S, Mengden T, Nürnberger J, Sanner B, Anlauf M. The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices: 15-year experience and results from 105 devices for home blood pressure control. Blood Press Monit. 2016 Aug;22(4):197-205. doi: 10.1097/MBP.0000000000000186. PMID: 26998590.
DHL:2007 - Pass General population (Note: 2009)
