EDAP TMS France SA

FDA Device Registration & Listing · Vaulx en Velin Rhone, FR · Registration 9612448

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9612448
FEI Number
3002806876
Entity Name
EDAP TMS France SA
City/State/Country
Vaulx en Velin Rhone, FR
Establishment Address
4 rue du Dauphine, Vaulx en Velin Rhone 69120, FR
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
EDAP TMS France (Owner Number: 8023014)
Owner / Operator Contact Address
4 RUE DU DAUPHINE, PARC D'ACTIVITES LA POUDRETTE LAMARTINE, VAULX-EN-VELIN, FR-NOTA 69120, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K172721
PMA Number
N/A

All Registered Proprietary Names

Sonolith I-move Ablatherm Integrated Imaging Focal One

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MMZ Table, Cystometric, Electric Gastroenterology, Urology Class 2 876.4890 2011-08-08
LNS Lithotriptor, Extracorporeal Shock-Wave, Urological Gastroenterology, Urology Class 2 876.5990 2011-08-08
PLP High Intensity Ultrasound System For Prostate Tissue Ablation Gastroenterology, Urology Class 2 876.4340 2015-11-10
PLP High Intensity Ultrasound System For Prostate Tissue Ablation Gastroenterology, Urology Class 2 876.4340 2018-11-02

Official Correspondent

No official correspondent registered.

US Agent Details

Hugo Embert Business: EDAP Technomed Inc Email: Hugo.Embert@FocalOne.com Phone: (512) 8327956

Related Public Records

Same Entity

EDAP TMS France
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612448. Last updated year: 2026. Please use registration number 9612448 when referencing this establishment in official correspondence.
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