Beurer GL 49 mmol/L
Device Model:
GL 49 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
Connected Health Technologies:
Bluetooth
Availability:
Available Currently
Description:
The Beurer GL 49 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.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Beurer GL 49 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 AssessmentRecommendationBasis
BG Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
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 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

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

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