Identity
- Trade Name
- FocalPak® Set EUDAMEDFocalpak Set EUDAMED
- Device Name
- FocalPak Set EUDAMED
- Model / Reference
- TMS 239357 EUDAMED239357 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661690000281 EUDAMED
- Basic UDI-DI
- 3661690FOCALPAKSETKU EUDAMEDB-03661690000281 EUDAMED
- EMDN Code
- U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMEDU1299 SINGLE-USE UROGENITAL INSTRUMENTATION (NON-ENDOSCOPIC) - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
FocalPak® Set by Edap-Tms France — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 3661690FOCALPAKSETKU | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 3661690FOCALPAKSETKU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Edap Tms France
- EUDAMED SRN
- FR-MF-000002207
Sources (2)
- EUDAMED db156ade-7c87-4169-b036-474c5d98e704 61 fields · synced Jul 25, 2026
- EUDAMED 6a605e4c-7a97-4b18-89ba-b6fb4ed61a0d 61 fields · synced May 18, 2026