URETHROTECH INC.

FDA Device Registration & Listing · Winston Salem, NC, US · Registration 3016998661

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016998661
FEI Number
3016998661
Entity Name
URETHROTECH INC.
City/State/Country
Winston Salem, NC, US
Establishment Address
111 N. Chestnut Street, Suite 104, Winston Salem, NC 27101, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Urethrotech Inc. (Owner Number: 10075263)
Owner / Operator Contact Address
111 N. Chestnut Street, Suite 104, Winston Salem, NC 27101, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K190060
PMA Number
N/A

All Registered Proprietary Names

Urethral Catheterisation Device (UCD®)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2025-07-15

Official Correspondent

Daniela Andrich

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Urethrotech Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K233013 Silq Technologies Corporation 2-Way 100% Silicone Cleartract Catheter 2024-01-23

Similar Registrations

Registration Number Establishment Name Location
3004070478 URO TECHNOLOGY SDN. BHD. PONTIAN Johor, MY
3014650073 Silq Technologies Corporation Sunny Isles Beach, FL, US
1018233 C.R. BARD, INC. COVINGTON, GA, US
3010400865 WELL LEAD MEDICAL CO. LTD GUANGZHOU Guangdong, CN
3015997711 KATMAI INTEGRATED SOLUTIONS Brilliant, OH, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016998661. Last updated year: 2026. Please use registration number 3016998661 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.