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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
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.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
ESH (Europe)Self-measurementPublished evidence

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