Esparma Gluco-Test Plus

Device Name:

Gluco-Test Plus

Device Model:

TD-4209

Manufacturer:

Distributer: Esparma GmbH, 1 Bielefeld Straße, 39171 Sülzetal OT, Osterweddingen, GERMANY.

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

Measuring functions:

Blood glucose

Primary Client Use:

Intended for both professional use and self-measurement

Measurement Site:

Finger and general Alternative Site Testing

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Description:

The Esparma Gluco-Test Plus is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for both professional use and self-measurement.

Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Esparma Gluco-Test Plus to measure blood glucose.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	Not recommended	This device has not been clinically validated.