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Integrated Continuous Glucose Monitoring System For Professional Retrospective Use

Integrated Continuous Glucose Monitoring System For Professional Retrospective Use is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

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Integrated Continuous Glucose Monitoring System For Professional Retrospective Use
Clinical Chemistry Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QDL

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Class 2

21 CFR 862.1355

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Clinical Chemistry

Device Characteristics

No

No

No

Not Eligible

Definition

An integrated continuous glucose monitoring system for professional retrospective use is a continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older for use by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.