Pure Global

Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management 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
Multi-Country Intelligence
Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management
Clinical Chemistry Medical Device Type
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Regulatory Classifications

US Regulatory Classifications

QDK

View Product Code Classification

Class 2

21 CFR 862.1355

View CFR Regulation

Clinical Chemistry

Device Characteristics

No

No

No

Not Eligible

Definition

An integrated continuous glucose monitoring system for non-intensive diabetes management is intended to replace finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes who do not have significant risk of severe hypoglycemia. The device also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments. The device is also intended to autonomously communicate with digitally connected devices. The device can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.

Search Keywords

Click to search for similar devices in our global database