Identity
- Trade Name
- Sonolith EUDAMED
- Device Name
- Pediatric support EUDAMED
- Model / Reference
- TMS 230270 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661690000250 EUDAMED
- Basic UDI-DI
- 3661690SUPPED78 EUDAMED
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Sonolith by Edap-Tms France — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3661690SUPPED78 | Class I | Unknown |
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Manufacturer
- Manufacturer
- Edap Tms France
- EUDAMED SRN
- FR-MF-000002207
Sources (1)
- EUDAMED 46b6304c-4542-4785-aae7-745b1a008d77 61 fields · synced May 22, 2026