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EDAP TMS France SA

France · Vaulx-En-Velin

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, 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

4listed device types

Class I 0Class II 4Class III 0

plus 6 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

1 including historic records

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

4active device licences

Class III 4

6 including historic records

TWTaiwanTFDA

4valid device licences

Class II 2Class III 2

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 1Class 2b 1

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 States6 registration records, 1 510(k), 0 PMA, 2 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: EDAP TMS France SA · EDAP TMS FRANCE

FDA 510(k) clearances by year

12011 · K111808

FDA listed device types

High Intensity Ultrasound System For Prostate Tissue Ablation 1Powered Laser Surgical Instrument 1Lithotriptor, Extracorporeal Shock-Wave, Urological 1Table, Cystometric, Electric 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K111808	SONOLITH I-MOVE	2011-08-01
SA	ME0000008390SFDAA00001	Sonolith® Electrode	—
CA	34326	SONOLITH PRAKTIS	Class III
CA	61857	SONOLITH VISION	Class III
CA	62247	ABLATHERM	Class III

EDAP TMS France SA

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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