Identity
- Trade Name
- Focal One endorectal probe EUDAMED
- Device Name
- Endorectal probe EUDAMED
- Model / Reference
- TMS 902000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661690000236 EUDAMED
- Basic UDI-DI
- B-03661690000236 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Focal One endorectal probe by Edap-Tms France — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03661690000236 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Edap Tms France
- EUDAMED SRN
- FR-MF-000002207
Sources (1)
- EUDAMED c02b10a7-f45a-4e7f-90c6-a796f8575125 61 fields · synced Jun 18, 2026