HoMedics Mibody 360EU

Device Name:Mibody
Device Model:360EU
Manufacturer:

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.

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
Assessment: The technology used in the HoMedics Mibody 360EU, to measure blood pressure, has been compared to a validated device but the results of the study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Validation Publications for Equivalent Devices

Note: Provisional list; equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) not proven

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: www.ncbi.nlm.nih.gov/pmc/articles/PMC2605325/pdf/vhrm-4-1121.pdf.

ESH-IP:2002 - Pass General population