Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009086335

FEI Number

3009086335

Entity Name

OPTIMUM MEDICAL

City/State/Country

West Yorkshire Leeds, GB

Establishment Address

Tennant Hall, Bleinheim Grove, West Yorkshire Leeds LS2 9ET, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Foreign Private Label Distributor,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Optimum Medical (Owner Number: 10041088)

Owner / Operator Contact Address

Tennant Hall, Bleinheim Grove, West Yorkshire, GB-LDS LS2 9ET, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OptiPure Sheath (Male External Catheters) Ovio Cup Ugo Fix Gentle catheter clip Ugo Hanger (Drainage Bag Holder) Ugo Drainage Leg Bags Ugo 2L Drainage Bags Ugo Fix Bag Belt Multi Fix Gentle Ugo Fix Sleeve Ugo Stand with Dignity Ugo Fix Catheter Strap Ugo Catheter Valve Nexus

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	2021-02-11
NNY	Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2019-09-24
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2020-11-24
NNZ	System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2018-01-17
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2018-01-17
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2025-04-04

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Optimum Medical

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 3009086335. Last updated year: 2026. Please use registration number 3009086335 when referencing this establishment in official correspondence.