Pricing Sign in

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

FocalPak Set — 1 UDI-DI variant, MDR (EDAP TMS FRANCE)

MD Atlas
EDAP TMS FRANCE

Data from EUDAMED, last updated May 19, 2026

FocalPak Set

3661690FOCALPAKSETKU

1 UDI-DI variant

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: EDAP TMS FRANCE

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Device characteristics

No device characteristics flagged

Clinical investigations

Registered: No

Registered: No

Registered: No

Identity & classification

Basic UDI-DI: 3661690FOCALPAKSETKU
Device name: FocalPak Set
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Jul 30, 2025

Manufacturer & authorised representative

Manufacturer

Name: EDAP TMS FRANCE
SRN: FR-MF-000002207
Country: France
Email: serviceAR@edap-tms.com
Phone: +33 472 153 150

Variants by status

UDI-DI variants

1 UDI-DI variant

Sign in to export

Exports are reserved for signed-in users. Sign in or create an account to continue.

Email

Password

No account yet?

Export results

Applied filters

basicUdiUlid01K1DPXECBGQB2QGNW9Y7WJ6MA

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

TMS 23935703661690000281