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External Urethral Occluder, Urinary Incontinence-Control, Female

External Urethral Occluder, Urinary Incontinence-Control, Female is a medical device type in the Gastroenterology, Urology 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
External Urethral Occluder, Urinary Incontinence-Control, Female
Gastroenterology, Urology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

MNG

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Class 1

21 CFR 876.5160

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Gastroenterology, Urology

Device Characteristics

No

No

No

Not Eligible

Definition

Intended to prevent or decrease episodes of urine leakage in women with stress incontinence. Occluder is applied to urinary meatus through suction or tape, which creates a barrier for urine leakage. Occluding device such as a cap, suction cup, or foam pad. May include adhesive gel or ointment.