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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Endorectal probe — Class IIb MDR by EDAP TMS FRANCE

MD Atlas
EDAP TMS FRANCE

EUDAMED last updated this device on Oct 10, 2025

Endorectal probe

3661690SONDEFO7M

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EDAP TMS FRANCE
UDI-DI code: 03661690000342
Reference / catalog number: TMS 253728

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Manufacturer information

Organization name: EDAP TMS FRANCE
SRN: FR-MF-000002207
Manufacturer status: —

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW012
EUDAMED did not publish a description for this code.
CW016
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Jul 24, 2025	Still on market

Device identification

Trade name: Endorectal probe
UDI-DI code: 03661690000342
Basic UDI-DI: 3661690SONDEFO7M
Reference / catalog number: TMS 253728
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://hifu.edaptms-academy.com/Library/FileExploreView
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

U99DEVICES FOR UROGENITAL SYSTEM - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Endorectal probe3661690SONDEFO7MOn the market TMS 2347803661690FOCALONE2ZOn the market TMS 2393573661690FOCALPAKSETKUOn the market TMS 2208303661690ELECTRODEFNOn the market Sonolith3661690SUPPED78On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.