Beurer GL 44 Lean mmol/L
Device Model:
GL 44 Lean mmol/L
Manufacturer:
OBL: Beurer GmbH, Söflinger Straße 218, 89077 Ulm, GERMANY.
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
Availability according to Countries or Regions:
United Kingdom, Spain, France and Italy
Device Manual:
Device Specifications:
Description:
The Beurer GL 44 Lean 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 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 Beurer GL 44 Lean mmol/L to measure blood glucose. However, this device appears to be very similar to a validated device by the same manufacturer or a device within a family of equivalent devices, 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:
Beurer GL 44 mg/dlZ, Beurer GL 44 Lean mg/dlZ, Beurer GL 44 Lean mmol/LZ, Beurer GL 44 mmol/LZ
Legend: Z Almost Certain
Legend: 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.
Beurer GL 44 mg/dl
Kenning M, Puchert A, Salzsieder E. System Accuracy Evaluation of Blood Glucose Monitoring Systems: Comparison of Four Devices for Personal Use Pursuant to ISO and ADA Guidelines. J Diabetes Sci Technol. 2021 Sep;15(5):1202-1203. Epub: 2021 May 12. doi: 10.1177/19322968211011185. PMID: 33978521. Available from: PMC8442185.
15197:2013 - Pass General population
FDA:2020H - Pass American Diabetes Accociation (ADA) protocol claimed but ADA reference refers to FDA 2020 and ISO 15197:2013