Identity
- Trade Name
- FocalPak Endo EUDAMED
- Device Name
- FocalPak/FocalPak Endo EUDAMED
- Model / Reference
- TMS 252833 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661690000298 EUDAMED
- Basic UDI-DI
- 3661690FOCALPAK2B EUDAMED
- EMDN Code
- U1299 SINGLE-USE UROGENITAL INSTRUMENTATION (NON-ENDOSCOPIC) - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Focalpak/FocalPak Endo are accessories of the Focal One. There are designed for acoustic coupling and cooling between tissues and endorectal probe. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
FocalPak Endo by Edap-Tms France — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3661690FOCALPAK2B | Class IIa | Active |
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Manufacturer
- Manufacturer
- Edap Tms France
- EUDAMED SRN
- FR-PR-000011354
Sources (1)
- EUDAMED 4a38971b-1e53-456e-ac7d-c7f6586ca5f9 61 fields · synced Jul 9, 2026