BIOS BD280
Device Model:
BD280
Manufacturer:
Distributer: Thermor Ltd., 16975 Leslie Street, Newmarket, Ontario L3Y 9A1, CANADA.
OBL: BIOS Medical, 16975 Leslie Street, Newmarket, Ontario L3Y 9A1, CANADA.
OEM: Microlife Corporation, 9F - 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN ROC.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for both ABPM and professional use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single and intermittent measurements
Availability:
Available Currently
Availability according to Countries or Regions:
Canada
Description:
The BIOS BD280 is an ambulatory blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for both ABPM and single measurements for professional use.
Assessment:
Medaval is in the process of checking the validation status of this device.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | While a clinical validation is claimed, it cannot be checked properly. |
| BP | Hypertension Canada | ABPM and self-measurement (Gold) | Manufacturer declaration of equivalence |