BIOS BD201 (Easy Read)
Device Name:
Easy Read
Device Model:
BD201
Manufacturer:
Distributer: Thermor Ltd., 16975 Leslie Street, Newmarket, Ontario L3Y 9A1, CANADA.
OBL: BIOS Medical, 16975 Leslie Street, Newmarket, Ontario L3Y 9A1, CANADA.
Measuring functions:
Blood Pressure and PR
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Canada
Device Manual:
Description:
The BIOS BD201 (Easy Read) is an automatic blood pressure monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
While the technology used in the BIOS BD201 (Easy Read), to measure blood pressure, has been declared as being equivalent to that used in another device, not only has 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, but there is no evidence provided on a validation of the other device.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | Not recommended | This device has not been shown to have been clinically validated. |
| BP | Hypertension Canada | Self-measurement (Silver) | Manufacturer declaration of equivalence |
Device Family: