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Beurer GL 34 mmol/L
Device Model:
GL 34 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:
Available Currently
Availability according to Countries or Regions:
Germany
Device Manual:
Description:
The Beurer GL 34 mmol/L is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. 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 34 mmol/L to measure blood glucose. However, this device appears to be very similar to another device by the same manufacturer or a device within a family of equivalent devices. At least one validation needs to be published and 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 Not recommended This device has not been shown to have been clinically validated.
Device Family:
Beurer GL 34 mg/dlZ, Beurer GL 34 mmol/LZ
Legend: Z Almost Certain