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Optimum Medical Ltd.

United Kingdom of Great Britain and Northern Ireland · Leeds · www.optimummedical.co.uk

✓ Record-verifiedregistrations found in 6 marketsEU SRN GB-MF-000005194

This company has registrations in European Union, United States, United Kingdom, Saudi Arabia, Australia, Israel — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

2UDI-DI device records

Class I 1Class IIb 1

USUnited StatesFDA openFDA

8listed device types

Class I 4Class II 4Class III 0

plus 8 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

25registered device records

Class I 22Class IIb 3

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

21active ARTG entries

Class I 12IIa 2IIb 2Class Is (sterile) 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

9registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union16 raw hits, 14 excluded, 2 confirmed

United States8 registration records, 0 510(k), 0 PMA, 2 excluded

United Kingdom25 confirmed, 2 excluded

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: OPTIMUM MEDICAL · Optimum Medical Solutions (OMS) · Optimum Medical Solutions LTD

Regulatory identity

EU manufacturer SRN: GB-MF-000005194
EU authorised representative: Medical Technology Promedt Consulting GmbH

Business registration

Legal name: OPTIMUM BIOMEDICAL LTD
Company number: 11860532
Registration status: Inactive
Legal form: Private Limited Company
Incorporated: 2019-03-05
Principal activity: 71122 - Engineering related scientific and technical consulting activities / 71200 - Technical testing and analysis
Registered address: 1ST FLOOR, FAIRCLOUGH HOUSE, CHORLEY, PR7 4EX

Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA listed device types

Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile 1System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile 1System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile 1Lubricant, Patient 1Urinary Drainage Collection Kit, For Indwelling Catheter 1Urinary Drainage Collection Kit 1Cup, Menstrual 1Catheter, Retention Type, Balloon 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	05061031580386	OPTILUBE JACKET	Class IIb
EU	05060222471625	Ugo Catheter Valve	Class I
UK	17541	OptiPure - 10ml sterile water pre-filled syringe	Class I
UK	60796	OptiLube 10g Tube	Class IIb
UK	32031	The Ugo Box Connect	Class IIb
SA	ME0000016257SFDAA00001	Vue Ultrasound Gel	—
SA	ME0000008950SFDAA00001	Glycerin Swabsticks	—

Optimum Medical Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA listed device types

Registration details (sample)

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