Edap Technomed Inc

FDA Filings

This page includes the latest FDA filings for Edap Technomed Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Edap Technomed Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1287394
FEI Number1287394
NameEdap Technomed Inc.
Owner & OperatorEDAP Technomed Inc.
Contact Address5321 Industrial Oaks Blvd. Suite 110
Austin TX 78735 US
Official Correspondent
  • Hugo Embert
  • x-512-8327956-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address5321 Industrial Oaks Blvd Suite 110
Austin, TX 78735 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Edap Technomed Inc.
Ablatherm Fusion2018-11-02
EDAP Technomed, Inc.
FOCAL ONE2018-06-07
Edap Technomed Inc.
Focal One2018-06-07
EDAP TECHNOMED, INC.
Ablatherm Fusion2017-10-03
EDAP TECHNOMED, INC.
Ablatherm Integrated Imaging2015-11-06
EDAP TECHNOMED, INC.
SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS2001-02-12

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