Identity
- Trade Name
- Focal One® EUDAMEDFocal One EUDAMED
- Device Name
- Focal One EUDAMED
- Model / Reference
- TMS 234780 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661690000267 EUDAMED
- Basic UDI-DI
- 3661690FOCALONE2Z EUDAMEDB-03661690000267 EUDAMED
- Direct Marketing DI
- 03661690000267 EUDAMED
- EMDN Code
- U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands 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
Focal One® by Edap-Tms France — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/MDR
European Union Unknown
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3661690FOCALONE2Z | Class IIb | Unknown |
| EUDAMED | European Union | CE/MDD | 3661690FOCALONE2Z | Class IIb | Unknown |
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Manufacturer
- Manufacturer
- Edap Tms France
- EUDAMED SRN
- FR-MF-000002207
Sources (2)
- EUDAMED 1563002a-6320-4917-b2de-ef519dad791e 61 fields · synced May 29, 2026
- EUDAMED 50df3963-709b-482c-8541-562b65d2b019 61 fields · synced May 17, 2026