HomeUnited Kingdom of Great Britain and Northern IrelandKeeler Limited

Keeler Limited

United Kingdom of Great Britain and Northern Ireland · Windsor
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, 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
21listed device types
Class I 8Class II 13Class III 0
plus 33 registration records and 9 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
7registered devices
Class I 7
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
6registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class II 1
9 including historic records
TWTaiwanTFDA
20valid device licences
Class I 12Class II 8
SGSingaporeHSA SMDR
3device registrations
CLASS B 3
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
15active ARTG entries
Class I 8IIa 3IIb 3Class Im (measuring) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
10active registrations
Class 1 1Class 2a 9
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 States33 registration records, 9 510(k), 0 PMA, 3 excluded
Brazil7 confirmed, 1 excluded
Saudi Arabia6 confirmed, 0 excluded
Canada1 confirmed, 1 excluded
Manufacturer names merged into this page: KEELER LTD. · KEELER LIMITED · Keeler Ltd.

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Windsor

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

Company number
00408759
Registration status
Active
Legal form
Private Limited Company
Incorporated
1946-04-18
Principal activity
32500 - Manufacture of medical and dental instruments and supplies
Registered address
CLEWER HILL ROAD, BERKSHIRE, SL4 4AA

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

12010
22013 · K131787
42014 · K142179
22015 · K152644

FDA listed device types

showing 8 of 21
Ophthalmoscope, Battery-Powered 1Tonometer, Ac-Powered 1Camera, Ophthalmic, Ac-Powered 1Transilluminator, Ac-Powered 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1Ophthalmoscope, Ac-Powered 1Laser, Ophthalmic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK152644KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 1002015-12-31
USK151394Keeler Slit Lamp2015-09-10
USK142179D-KAT Z-YPE2014-09-17
BR80891620082Otoscópio KeelerClass I
BR80117581283Otoscópio KeelerClass I
BR80117581284Retinoscópio KeelerClass I
SAME0000001544SFDAA00022Frames
SAME0000001544SFDAA00023K-LED II
CA94059HD ANALYZERClass II

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