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Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use

Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time 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.

Global Registration Data
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Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use
Clinical Chemistry Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QII

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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 directed retrospective or real-time use is a continuous glucose recording device indicated for use as directed by a physician either for the real-time management of diabetes at home or for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.