Beurer GL 49 mg/dl
Device Model:
GL 49 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
Connected Health Technologies:
Bluetooth
Availability:
Available Currently
Description:
The Beurer GL 49 mg/dl is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 3-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 49 mg/dl, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in two clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval ★★★ Recommendation Recent clinical validation; recent protocol; multiple clinical validations
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

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

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 48 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

© Medaval Ltd. Please read the Terms and Conditions before using this site.