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Automated Insulin Dosing Device System, Single Hormonal Control

Automated Insulin Dosing Device System, Single Hormonal Control is a medical device type in the Unknown 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
Multi-Country Intelligence
Automated Insulin Dosing Device System, Single Hormonal Control
Unknown Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OZP

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Class 3

21 CFR

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Unknown

Device Characteristics

No

No

No

Not Eligible

Definition

An insulin-only automated insulin dosing system that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump. Insulin adjustments are based upon specified thresholds of measured glucose levels.