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85 device results listed.

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VIOLA

Class IIaMDDOn the marketActive device

Manufacturer: AMI INC.
Manufacturer SRN: KR-MF-000017522
UDI-DI: 08800042100216
Basic UDI-DI: B-08800042100216
Reference: AMI-CL-0811
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: Lithuania
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details

Tightan Pro

Class IIaMDDOn the marketActive device

Manufacturer: WON TECH Co., Ltd
Manufacturer SRN: KR-MF-000016169
UDI-DI: 08800022301374
Basic UDI-DI: B-08800022301374
Reference: Focused Ultrasound Stimulator System
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: Slovakia
Authorised representative: mdi Europa GmbH
Last updated: 09.07.2026 20:42

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N13 Cartridge

Class IIbMDDOn the marketActive device

Manufacturer: Jeisys Medical Inc.
Manufacturer SRN: KR-MF-000008513
UDI-DI: 08800020109095
Basic UDI-DI: B-08800020109095
Reference: N13 Cartridge
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 09.07.2026 20:06

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L13 Cartridge

Class IIbMDDOn the marketActive device

Manufacturer: Jeisys Medical Inc.
Manufacturer SRN: KR-MF-000008513
UDI-DI: 08800020109088
Basic UDI-DI: B-08800020109088
Reference: L13 Cartridge
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 09.07.2026 20:06

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L8 Cartridge

Class IIbMDDOn the marketActive device

Manufacturer: Jeisys Medical Inc.
Manufacturer SRN: KR-MF-000008513
UDI-DI: 08800020109064
Basic UDI-DI: B-08800020109064
Reference: LIPOcel_L8 Cartridge
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 09.07.2026 20:06

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L4.5 Cartridge

Class IIbMDDOn the marketActive device

Manufacturer: Jeisys Medical Inc.
Manufacturer SRN: KR-MF-000008513
UDI-DI: 08800020109057
Basic UDI-DI: B-08800020109057
Reference: L4.5 Cartridge
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 09.07.2026 20:06

Manufacturer products Authorised representative products Authorised representative actors View details

L11 Cartridge

Class IIbMDDOn the marketActive device

Manufacturer: Jeisys Medical Inc.
Manufacturer SRN: KR-MF-000008513
UDI-DI: 08800020109071
Basic UDI-DI: B-08800020109071
Reference: L11 Cartridge
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 09.07.2026 20:06

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Sonotrip V20

Class IIbMDDNo longer on the marketActive device

Manufacturer: Jeisys Medical Inc.
Manufacturer SRN: KR-MF-000008513
UDI-DI: 08800020101877
Basic UDI-DI: B-08800020101877
Reference: 17
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 09.07.2026 20:05

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High Intensity Focused Ultrasonic Equipment

HIPRO

Class IIaMDDOn the marketActive deviceReusable

Manufacturer: DAEJU MEDITECH ENGINEERING CO., LTD
Manufacturer SRN: KR-MF-000020683
UDI-DI: 08800017500089
Basic UDI-DI: B-08800017500089
Reference: DJMD0001
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: Türkiye
Authorised representative: Javitech Consulting GmbH
Last updated: 09.07.2026 19:59

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Ulfit

Focused Ultrasound Therapeutic Equipment

Class IIaMDDOn the marketActive device

Manufacturer: CLASSYS
Manufacturer SRN: KR-MF-000010116
UDI-DI: 08800016900446
Basic UDI-DI: B-08800016900446
Reference: UF1-M200
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 09.07.2026 19:57

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ULTRAFORMER III

Focused Ultrasound Therapeutic Equipment

Class IIaMDDOn the marketActive device

Manufacturer: CLASSYS
Manufacturer SRN: KR-MF-000010116
UDI-DI: 08800016900026
Basic UDI-DI: B-08800016900026
Reference: UF3-M300
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 09.07.2026 19:57

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FISIOSONIC

Class IIaMDDOn the marketActive deviceContains latex

Manufacturer: FISIOLINE SRL
Manufacturer SRN: IT-MF-000027924
UDI-DI: 08057949170563
Basic UDI-DI: B-08057949170563
Reference: FISIOSONICR3
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:38

Manufacturer products View details

qmd ultrasound cryo thermal

Class IIbMDDOn the marketActive device

Manufacturer: Hakomed Italia Srl
Manufacturer SRN: IT-MF-000031004
UDI-DI: 08056999870164
Basic UDI-DI: B-08056999870164
Reference: Q-0305
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:32

Manufacturer products View details

MIXING2

3M00

Class IIbMDDOn the marketActive device

Manufacturer: Project Blue Generation s.r.l.
Manufacturer SRN: IT-MF-000027914
UDI-DI: 08055719580116
Basic UDI-DI: B-08055719580116
Reference: 3M00
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:00

Manufacturer products View details

US13

ILINE.US13

Class IIaMDDOn the marketActive device

Manufacturer: Project Blue Generation s.r.l.
Manufacturer SRN: IT-MF-000027914
UDI-DI: 08055719580048
Basic UDI-DI: B-08055719580048
Reference: ILINE.US13
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:00

Manufacturer products View details

Sofwave

FG00001INT

Class IIaMDDOn the marketActive device

Manufacturer: Sofwave Medical Ltd.
Manufacturer SRN: IL-MF-000019200
UDI-DI: 07290018152003
Basic UDI-DI: B-07290018152003
Reference: FG00001INT
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 07.07.2026 03:10

Manufacturer products Authorised representative products Authorised representative actors View details

High Intensity Focused Ultrasound System

PRO2008

Class IIbMDDOn the marketActive deviceReusable

Manufacturer: Shenzhen PRO HITU Medical Co., Ltd.
Manufacturer SRN: CN-MF-000021578
UDI-DI: 06975039130094
Basic UDI-DI: B-06975039130094
Reference: MDD2022MA3375
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:29

Manufacturer products Authorised representative products Authorised representative actors View details

PRO300

Class IIbMDDOn the marketActive deviceReusable

Manufacturer: Shenzhen PRO HITU Medical Co., Ltd.
Manufacturer SRN: CN-MF-000021578
UDI-DI: 06975039130018
Basic UDI-DI: B-06975039130018
Reference: PRO300
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: Türkiye
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:29

Manufacturer products Authorised representative products Authorised representative actors View details

PRO2008

Class IIbMDDOn the marketActive deviceReusable

Manufacturer: Shenzhen PRO HITU Medical Co., Ltd.
Manufacturer SRN: CN-MF-000021578
UDI-DI: 06975039130001
Basic UDI-DI: B-06975039130001
Reference: PRO2008
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: Türkiye
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:29

Manufacturer products Authorised representative products Authorised representative actors View details

00850071153255

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