Identity
- Trade Name
- Sonolith EUDAMEDEndo-i-move Table FDA UDI
- Generic Name
- Electromechanical lithotripsy system, extracorporeal FDA UDI
- Device Name
- Endo I-Move table EUDAMEDA table for use with the SONOLITH® i-move medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). FDA UDI
- Model / Reference
- TMS 233101 EUDAMEDFDA UDI
- Description
- A table for use with the SONOLITH® i-move medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). FDA UDI
Identifiers
- Catalog Number
- TMS233101 FDA UDI
- Primary DI / UDI-DI
- 03661690000090 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661690TEIM67 EUDAMED
- 510(k) Number
- K111808 FDA UDI
- FDA Product Code
- MMZ FDA UDI
- EMDN Code
- Z12011202 OPERATING TABLES 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
- 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
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
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 I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3661690TEIM67 | Class I | Active |
| 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 9b6fd2f8-3ea0-4a0f-86ad-a8800c9ef0c8 61 fields · synced Jul 11, 2026
- FDA UDI 0aab3c01-5768-465f-a2ac-a129b8254003 37 fields · synced May 24, 2026