Medisante BP800/D40g

Device Model:

BP800, D40g

Manufacturer:

OBL: Medisanté Group AG, Wesemlinrain 16, 6006 Luzern, SWITZERLAND.

OEM: TaiDoc Technology Corporation, 6F - 127 Wugong 2nd Road, 24888 Wugu District, New Taipei City, TAIWAN ROC.

Measuring functions:

Blood pressure, Blood glucose

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

BP: Upper Arm; BG: Finger

Measurement Occurrence:

BP & BG: Single measurements only

Availability:

Available Currently

Description:

The Medisante BP800/D40g is a dual monitor for blood pressure and blood glucose. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology and blood glucose measurement technology. Blood pressure measurements are taken from the upper arm and blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.

Assessment:

The Medisante BP800/D40g is included in a current validation and equivalence audit, by Medaval. Validation details will be posted when this has been completed.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	Not recommended	This device has not been shown to have been clinically validated.

Device Family:

Fora Duo Ultima (D40a)Z, Fora Duo Ultima (D40 Pro)Z, Fora Duo Ultima (D40b)Z, Fora Duo Ultima (D40g)Z, Fora Duo Ultima (D40d)Z, Medisante BP800/D40gZ, TaiDoc TD-3261BZ, TaiDoc TD-3261GZ
Legend: Z Almost Certain