HomeUnited Kingdom of Great Britain and Northern IrelandDE SOUTTER MEDICAL LIMITED

DE SOUTTER MEDICAL LIMITED

United Kingdom of Great Britain and Northern Ireland · Aylesbury
✓ 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
8listed device types
Class I 7Class II 1Class III 0
plus 8 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
16registered devices
Class II 16
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
20active device licences
Class II 20
TWTaiwanTFDA
4valid device licences
Class I 4
SGSingaporeHSA SMDR
7device registrations
CLASS B 7
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
17active ARTG entries
Class I 9IIa 7IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
3active registrations
Class 2a 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 States8 registration records, 2 510(k), 0 PMA
Brazil16 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Canada20 confirmed, 0 excluded
Manufacturer names merged into this page: DE SOUTTER MEDICAL LTD. · DE SOUTTER MEDICAL USA, Inc · DE SOUTTER MEDICAL LIMITED · DE SOUTTER MEDICAL LIMITED AND HALTON BROOK BUSINESS PARK · De Soutter Medical Ltd.
Same-named companies — This database also contains companies with near-identical names: DE SOUTTER MEDICAL USA, Inc. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Aylesbury

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
03164365
Registration status
Active
Legal form
Private Limited Company
Incorporated
1996-02-26
Principal activity
32500 - Manufacture of medical and dental instruments and supplies
Registered address
1 HALTON BROOK BUSINESS PARK, AYLESBURY, HP22 5WF

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

21993 · K930785

FDA listed device types

Motor, Surgical Instrument, Ac-Powered 1Instrument, Cast Removal, Ac-Powered 1Component, Cast 1Bur, Surgical, General & Plastic Surgery 1Motor, Surgical Instrument, Pneumatic Powered 1Orthopedic Manual Surgical Instrument 1Dermatome 1Lavage, Jet 1

Registration details (sample)

MarketIdentifierNameClass / date
USK930785THE DE SOUTTER M182 DRILL1993-10-27
USK930784THE DE SOUTTER M193 REAMER1993-10-27
BR10056340130Sistema de motores elétricos para pequenos ossos De SoutterClass II
BR10056340131SHAVER DE SOUTTERClass II
BR10056340122BROCAS, FRESAS E CRANIÓTOMOS STERICUTClass II
SAME0000006917SFDAA00001CC5 CAST SAW-VAC
CA92101DBK-700 SAGITTAL SAW HANDPIECEClass II
CA92109TRAUMADRIVEClass II
CA92110STERNUDRIVE PNEUMATIC STERNUM SAW SYSTEMClass II

Similar companies

2BScientific Ltd.
United Kingdom of Great Britain and Northern Ireland · markets 0
AbBaltis Ltd
United Kingdom of Great Britain and Northern Ireland · markets 0
Advanced Molecular Diagnostics Ltd.
United Kingdom of Great Britain and Northern Ireland · markets 3
Air Moving Products Ltd Trading as Steady Moto
United Kingdom of Great Britain and Northern Ireland · markets 0
Albert Waeschle Ltd
United Kingdom of Great Britain and Northern Ireland · markets 3
Alerta Medical Ltd.
United Kingdom of Great Britain and Northern Ireland · markets 5
Is this your company? Claim the page, add information or report a data error.Claim / report an error →