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Uterine Electromyographic Monitor

Uterine Electromyographic Monitor is a medical device type in the Obstetrics/Gynecology 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
Uterine Electromyographic Monitor
Obstetrics/Gynecology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OSP

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Class 2

21 CFR 884.2720

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Obstetrics/Gynecology

Device Characteristics

No

No

No

Not Eligible

Definition

The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton pregnancy.