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TREK DIAGNOSTIC SYSTEMS LIMITED

United Kingdom of Great Britain and Northern Ireland · East Grinstead

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

pendingnot queried

USUnited StatesFDA openFDA

11listed device types

Class I 4Class II 7Class III 0

plus 84 registration records and 68 510(k), 6 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 2Class II 5

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

1active device licences

Class III 1

3 including historic records

TWTaiwanTFDA

6valid device licences

Class I 4Class II 2

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

3active ARTG entries

IVD Class 1 1IVD Class 2 2

HKHong KongMDACS

7valid listings

IVD B 7

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

4active registrations

Class 1 2Class 2a 2

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.

United States84 registration records, 68 510(k), 6 PMA, 3 excluded

Brazil7 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: TREK DIAGNOSTIC SYSTEMS, LTD. · TREK DIAGNOSTIC SYSTEMS LTD. · TREK DIAGNOSTIC SYSTEMS · TREK DIAGNOSTIC SYSTEMS LIMITED

Business registration

Company number: 02038515
Registration status: Active
Legal form: Private Limited Company
Incorporated: 1986-07-18
Principal activity: 82990 - Other business support service activities n.e.c.
Registered address: 3RD FLOOR,, ALTRINCHAM, WA14 2DT

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

FDA 510(k) clearances by year

11998

11999

42000

142001

92002

52003

42004

12005

112006

42008

42009

22010

72011

12014

FDA listed device types

showing 8 of 11

Manual Antimicrobial Susceptibility Test Systems 1Reagent/Device, Inoculum Calibration 1Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems 1Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth 1Susceptibility Test Plate, Antifungal 1Susceptibility Test Cards, Antimicrobial 1Panels, Test, Susceptibility, Antimicrobial 1Gram Negative Identification Panel 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K133038	SENSITITRE YEASTONE SUSCEPTIBILITY PLATES	2014-01-31
US	K112276	VIZION	2011-11-16
US	K111615	SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES	2011-11-08
BR	80254180259	Sensititre Vizion	Class II
BR	80254180269	Família Sensititre para testes de Suscetibilidade a Antimicrobianos	Class II
BR	80254180484	Sensititre YeastOne - YO10	Class II
CA	77699	LEADCARE II BLOOD LEAD TESTING SYSTEM	Class III