Beurer GL 48 mg/dl
Device Model:
GL 48 mg/dl
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:
Available Currently
Device Manual:
Click here to download the Device Manual
Description:
The Beurer GL 48 mg/dl is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
The technology used in the Beurer GL 48 mg/dl, to measure blood glucose, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval ★★ Recommendation Recent clinical validation; recent protocol
Device Family:
Beurer GL 48 mg/dlZ, Beurer GL 48 mmol/LZ, Beurer GL 49 mg/dlZ, Beurer GL 49 mmol/LZ
Legend: Z Almost Certain
Validation Publications:

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

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 49 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

Kenning M, Puchert A, Salzsieder E. System Accuracy Evaluation of a Blood Glucose Monitoring System. J Diabetes Sci Technol. 2022 Mar;16(2):574-575. Epub: 2021 Nov 15. doi: 10.1177/19322968211057534. PMID: 34781779. Available from: PMC8861790.

15197:2013 - Pass General population

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