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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

17.07.2026 00:09

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Active filter:Manufacturer SRN:US-MF-000012164

4 device results listed.

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Sonablate HIFU consumables

Class IMDR 2017/745On the marketSingle use

Manufacturer: Focus Surgery, Inc.
Manufacturer SRN: US-MF-000012164
UDI-DI: 00850071153064
Basic UDI-DI: 00850071153HIFUkitsX2
Reference: E01017AST61
EMDN: Z12160385
EMDN description: PROSTATE THERMOTHERAPY INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 22:35

Manufacturer products Authorised representative products Authorised representative actors View details

Sonablate

Class IIbMDDNo longer on the marketActive device

Manufacturer: Focus Surgery, Inc.
Manufacturer SRN: US-MF-000012164
UDI-DI: 00850071153255
Basic UDI-DI: B-00850071153255
Reference: Sonablate
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: -
Authorised representative: CEpartner4U
Last updated: 05.07.2026 11:04

Manufacturer products Authorised representative products Authorised representative actors View details

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Class IMDR 2017/745On the marketSingle use

Manufacturer: Focus Surgery, Inc.
Manufacturer SRN: US-MF-000012164
UDI-DI: 00850071153088
Basic UDI-DI: 00850071153HIFUkitsX2
Reference: 411-12017-0001
EMDN: Z12160385
EMDN description: PROSTATE THERMOTHERAPY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: AR Experts B.V.
Last updated: 22.06.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details

O-Ring Applicator Tool

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Class IMDR 2017/745On the marketSingle use

Manufacturer: Focus Surgery, Inc.
Manufacturer SRN: US-MF-000012164
UDI-DI: 00850071153101
Basic UDI-DI: 00850071153HIFUkitsX2
Reference: 302-08119-1002
EMDN: Z12160385
EMDN description: PROSTATE THERMOTHERAPY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: AR Experts B.V.
Last updated: 22.06.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details