FDA.reportPublic FDA data

EDAP TMS France SA

Matched from indexed company URL: EDAP TMS FRANCE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96124483002806876EDAP TMS France SA1N2026-01-014 rue du Dauphine Vaulx en Velin Rhone FR 69120

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
949971129547606K251910Focal One®PLP2025-11-19
949971380913165K172721FOCAL ONEPLP2018-06-07
949971178667234K172285Ablatherm FusionPLP2017-10-03
949971994321707K153023Ablatherm Integrated ImagingPLP2015-11-06
949971652784841K111808SONOLITH I-MOVELNS2011-08-01
949971414479143K083614SONOLITH I-SYS LITHOTRIPERLNS2009-07-27
949971022060244K003529SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTISLNS2001-02-12
949972069762747

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PLP42025-11-19
LNS32011-08-01

PMN#