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Sonolith Carbon Fiber Table

FDA UDIEUDAMED

Class II (US FDA UDI)

by Edap-Tms France

Identity

Trade Name
Sonolith Carbon Fiber Table FDA UDI
Generic Name
Electromechanical lithotripsy system, extracorporeal FDA UDI
Device Name
One piece carbon fiber table for use with SONOLITH® i-move or i-sys lithotripsy devices for ESWL(Extracorporeal Shock Wave Lithotnpsy). FDA UDI
Model / Reference
TMS 230811 FDA UDI
Description
One piece carbon fiber table for use with SONOLITH® i-move or i-sys lithotripsy devices for ESWL(Extracorporeal Shock Wave Lithotnpsy). FDA UDI

Identifiers

Catalog Number
TMS230811 FDA UDI
Primary DI / UDI-DI
03661690000083 FDA UDI
FDA Product Code
MMZ FDA UDI
GMDN Term
Electromechanical lithotripsy system, extracorporeal FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4890 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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 Carbon Fiber Table by Edap-Tms France — Class II — MDR, MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edap-Tms France

Sources (2)

  • FDA UDI 90bcccfe-f347-4ed5-90cb-8837ac59c96e 36 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026