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Sonolith

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref TMS 239270Model Sonolith i-move Touch510(k) K111808

by Edap Tms France

Identity

Trade Name
Sonolith EUDAMED
Sonolith i-move Touch Module FDA UDI
Generic Name
Electromechanical lithotripsy system, extracorporeal FDA UDI
Device Name
Sonolith i-move EUDAMED
SONOLITH® i-move Touch medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physical principle consists in delivering pulsed pressure waves which are focalized on the stone to be treated, at fixed frequency or patient synchronized frequency. FDA UDI
Model / Reference
Sonolith i-move Touch EUDAMED
TMS 239270 EUDAMEDFDA UDI
Description
SONOLITH® i-move Touch medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physical principle consists in delivering pulsed pressure waves which are focalized on the stone to be treated, at fixed frequency or patient synchronized frequency. FDA UDI

Identifiers

Catalog Number
TMS 239270 FDA UDI
Primary DI / UDI-DI
03661690000120 EUDAMEDFDA UDI
Basic UDI-DI
B-03661690000120 EUDAMED
510(k) Number
K111808 FDA UDI
FDA Product Code
LNS FDA UDI
EMDN Code
Z12160101 EXTRACORPOREAL LITHOTRIPTERS EUDAMED
GMDN Term
Electromechanical lithotripsy system, extracorporeal FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
876.5990 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sonolith by Edap-Tms France — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Unknown

CE/MDD

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Manufacturer

Manufacturer
Edap Tms France
EUDAMED SRN
FR-MF-000002207

Sources (3)

  • EUDAMED 3a80ccf8-8908-499e-8433-1985133821ab 85 fields · synced Jun 18, 2026
  • FDA UDI 3552dae3-ff2b-420a-8cb2-2c16f326ed9c 37 fields · synced May 30, 2026
  • FDA 510(k) K111808 1 fields · synced May 18, 2026