OBL: HoMedics Inc., 3000 Pontiac Trail, Commerce Township, MI 48390, UNITED STATES.
OEM: Oregon Scientific Inc., 10778 SW Manhasset Drive, Tualatin, OR 97062, UNITED STATES.
|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.|
Legend: B BIHS Derivative
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.
Oregon BPU 330
Li L, Zhang X, Yan C, Liang Q. Validation of the Oregon Scientific BPU 330 for self-monitoring of blood pressure according to the International Protocol. Vasc Health Risk Manag. 2008;4(5):1121-5. PMID: 19183762. Available from: PMC2605325.
ESH-IP:2002 - Pass General population