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DE SOUTTER MEDICAL USA, Inc

USA · Mooresville

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

12registered devices

Class II 12

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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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.

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

Brazil12 confirmed, 1 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 Ltd.

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)

Market	Identifier	Name	Class / date
US	K930785	THE DE SOUTTER M182 DRILL	1993-10-27
US	K930784	THE DE SOUTTER M193 REAMER	1993-10-27
BR	10056340130	Sistema de motores elétricos para pequenos ossos De Soutter	Class II
BR	10056340131	SHAVER DE SOUTTER	Class II
BR	10056340122	BROCAS, FRESAS E CRANIÓTOMOS STERICUT	Class II
SA	ME0000006917SFDAA00001	CC5 CAST SAW-VAC	—
CA	92101	DBK-700 SAGITTAL SAW HANDPIECE	Class II
CA	92109	TRAUMADRIVE	Class II
CA	92110	STERNUDRIVE PNEUMATIC STERNUM SAW SYSTEM	Class II

DE SOUTTER MEDICAL USA, Inc

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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