BIOS BD204 (Precision 4.0)
Device Name:
Precision 4.0
Device Model:
BD204
Manufacturer:
OBL: BIOS Medical, 16975 Leslie Street, Newmarket, Ontario L3Y 9A1, CANADA.
OEM: Shanghai Honsun International Trade Co. Ltd., Room C. Floor 22, Zhiyuan Building, 768 Xietu Road, Shanghai 200023, CHINA.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Discontinued but still available
Availability according to Countries or Regions:
Canada
Device Manual:
Description:
The BIOS BD204 (Precision 4.0) is an automatic 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 self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
The technology used in the BIOS BD204 (Precision 4.0), to measure blood pressure, has been compared to a clinically validated device, but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
| Accuracy Assessment | Recommendation | Basis |
| BP |
Medaval |
None |
Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
| BP |
ESH (Europe) |
Self-measurement |
Published evidence |
Device Family:
BIOS BD204 (Precision 4.0)D,
Honsun Scian LD-533B,
Honsun Scian LD-520B,
Honsun Scian LD-522B,
Honsun Scian LD-528B,
Honsun Scian LD-530B,
Honsun Scian LD-532B,
Honsun Scian LD-562B,
Honsun Scian LD-568 (V1)B,
Honsun Scian LD-578B,D,
Honsun Scian LD-582B,
Honsun Scian LD-586NB,
Honsun Scian LD-587B,
Honsun Scian LD-588B,
Honsun Scian LD-526B,
Honsun LD30B,
Little Doctor LD51AB,
Little Doctor LD51UB,
Little Doctor LD51B,
Little Doctor LD51SB,
Little Doctor LD-521AB,
Little Doctor LD-521B,
Suresign LD3B,
Suresign LD-588B,
Timesco D05.230ZLegend:
B BIHS Derivative,
D DET Equivalence,
Z Almost Certain
Validation Publications for Equivalent Devices:
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.
Honsun Scian LD-578
Zhang Y, Wang J, Huang QF, Sheng CS, Li Y, Wang JG. Validation of the HONSUN LD-578 blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol. Blood Press Monit. 2009 Jun;14(3):128-31. doi: 10.1097/MBP.0b013e32832ce149. PMID: 19454866.
ESH-IP:2002 - Pass General population
