Identity
- Trade Name
- Sonolith EUDAMEDSonolith Electrode FDA UDI
- Generic Name
- Electromechanical lithotripsy system, extracorporeal FDA UDI
- Device Name
- Sonolith Electrode EUDAMEDThe SONOLITH® electrode is the consumable/ disposable component for the SONOLITH® 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
- TMS 220830 EUDAMEDFDA UDI
- Description
- The SONOLITH® electrode is the consumable/ disposable component for the SONOLITH® 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
- TMS220830 FDA UDI
- Primary DI / UDI-DI
- 03661690000045 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661690ELECTRODEFN EUDAMED
- 510(k) Number
- K111808 FDA UDI
- FDA Product Code
- MMZ FDA UDI
- EMDN Code
- Z12160185 EXTRACORPOREAL LITHOTRIPSY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Electromechanical lithotripsy system, extracorporeal FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4890 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sonolith by Edap-Tms France — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3661690ELECTRODEFN | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Edap Tms France
- EUDAMED SRN
- FR-MF-000002207
Sources (2)
- EUDAMED bc1cc52a-4f98-4160-8475-dfdbf6e285c9 61 fields · synced May 30, 2026
- FDA UDI 3347a986-2d0d-4ee3-901f-7e16cdd492e1 37 fields · synced May 30, 2026