Beurer GL 32 mmol/L
Device Model:
GL 32 mmol/L
Manufacturer:
OBL: Beurer GmbH, Söflinger Straße 218, 89077 Ulm, GERMANY.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Discontinued but still available
Device Manual:
Device Specifications:
Description:
The Beurer GL 32 mmol/L is an automatic blood glucose meter. The accuracy of its blood glucose measurement technology has yet to be proven to MDR requirements. Blood glucose measurements are taken from the finger. 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:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Beurer GL 32 mmol/L to measure blood glucose. However, this device appears to be very similar to a validated device by the same manufacturer, but equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
Device Family:
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.
Beurer GL 32 mg/dl
Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1060-75. PMID: 23063032. Available from: PMC3570840.
15197:2003 - Pass General population
15197:2013 - Fail General population