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Dario Blood Glucose Monitoring System

LABSTYLE INNOVATION LTD · Model 1015-01 · UDI-DI 00850065006000

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510(k) clearances
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Adverse events
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Recalls
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Facilities

Description

The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.