Identity
- Trade Name
- Endorectal probe EUDAMEDFocal One endorectal probe EUDAMEDDynamic Focal Probe FDA UDI
- Generic Name
- Physical therapy ultrasound system FDA UDI
- Device Name
- Endorectal probe EUDAMEDThe Dynamic Focal Probe is a primary component of the Focal One system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via this probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated. FDA UDI
- Model / Reference
- TMS 902081 EUDAMEDFDA UDIEB EUDAMED
- Description
- The Dynamic Focal Probe is a primary component of the Focal One system which is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via this probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated. FDA UDI
Identifiers
- Catalog Number
- TMS 902081 FDA UDI
- Primary DI / UDI-DI
- 03661690000205 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661690SONDEFO7M EUDAMEDB-03661690000205 EUDAMED
- Direct Marketing DI
- 03661690000205 EUDAMED
- 510(k) Number
- K172721 FDA UDI
- FDA Product Code
- PLP FDA UDI
- EMDN Code
- U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMED
- GMDN Term
- Physical therapy ultrasound system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4340 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Endorectal probe by Edap-Tms France — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 3661690SONDEFO7M | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 3661690SONDEFO7M | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Edap Tms France
- EUDAMED SRN
- FR-MF-000002207
Sources (3)
- EUDAMED c3e42aa7-ee31-419d-9a18-b9eded524157 61 fields · synced Sep 18, 2026
- EUDAMED 3116625a-e4e6-4fb0-ad2e-83a98d7ee516 61 fields · synced May 18, 2026
- FDA UDI 2840e852-f95a-48fd-be93-46ea789e1910 36 fields · synced May 30, 2026