Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016738724

FEI Number

3016738724

Entity Name

URETHROTECH

City/State/Country

Kingston upon Thames Surrey, GB

Establishment Address

24 Garth Road, Kingston upon Thames Surrey KT2 5NY, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Urethrotech (Owner Number: 10069409)

Owner / Operator Contact Address

24 Garth Road, Kingston upon Thames, GB-SRY KT2 5NY, GB

Initial Importer Flag

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	2020-04-12

Official Correspondent

Daniela Andrich

US Agent Details

Pamela Papineau Business: Delphi Medical Device Consulting, Inc. Email: delphimdc@comcast.net Phone: (978) 7588322

Related Public Records

Same Entity

Urethrotech

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 3016738724. Last updated year: 2026. Please use registration number 3016738724 when referencing this establishment in official correspondence.