Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003477176

FEI Number

3003477176

Entity Name

UROMEDICA, INC.

City/State/Country

PLYMOUTH, MN, US

Establishment Address

1840 Berkshire Ln N, PLYMOUTH, MN 55441, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

UROMEDICA, INC. (Owner Number: 9047760)

Owner / Operator Contact Address

1840 BERKSHIRE LN. NORTH, --, Plymouth, MN 55441, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P130018

All Registered Proprietary Names

ProACT Implantation Instrument Set ProACT Blunt Trocar ProACT Tissue Expanding Device II ProACT Adjustable Continence Therapy for Men

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EZY	Device, Incontinence, Mechanical/Hydraulic	Gastroenterology, Urology	Class 3	876.5280	2017-08-24

Official Correspondent

Timothy Cook

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

UROMEDICA, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003477176. Last updated year: 2026. Please use registration number 3003477176 when referencing this establishment in official correspondence.