Omron Pro Logic PL100 (HEM-7101-PR)

Device Name:Pro Logic PL100
Device Model:HEM-7101-PR
Manufacturer:Sole: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600 8530, JAPAN.
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:

While the technology used in the Omron Pro Logic PL100 (HEM-7101-PR), to measure blood pressure, has been declared as being equivalent to that used in a 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.

It is recommended by the BIHS on the basis of a manufacturer declaration of equivalence. It is recommended by the ESH for self-measurement.