HomeUnited Kingdom of Great Britain and Northern IrelandJames Leckey Design Ltd

James Leckey Design Ltd

United Kingdom of Great Britain and Northern Ireland · Lisburn Lisburn And Castlereagh
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Australia, Israel, Russia — 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
pendingnot queried
USUnited StatesFDA openFDA
2listed device types
Class I 2Class II 0Class III 0
plus 2 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
8registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
5valid device licences
Class I 5
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
13active ARTG entries
Class I 13
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
3active registrations
Class 1 3
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 States2 registration records, 2 510(k), 0 PMA
Saudi Arabia8 confirmed, 0 excluded
Manufacturer names merged into this page: James Leckey Design Ltd

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Lisburn Lisburn And Castlereagh

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
JAMES LECKEY DESIGN LIMITED
Company number
NI023037
Registration status
Active
Legal form
Private Limited Company
Incorporated
1989-09-01
Principal activity
32500 - Manufacture of medical and dental instruments and supplies
Registered address
19 BALLINDERRY ROAD, LISBURN, BT28 2SA

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

21994 · K944308

FDA listed device types

Adaptor, Recreational 1Exerciser, Non-Measuring 1

Registration details (sample)

MarketIdentifierNameClass / date
USK944308JAMES LECKEY FREE STANDER1994-12-22
USK944307JAMES LECKEY PRONE STANDER1994-12-22
SAME0000008572SFDAA00008GottaGo
SAME0000008572SFDAA00001Mygo Seating System

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