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EUDAMED Device Search

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

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17 device results listed.

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Proton Therapy System

PROBEAT-LL

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04560333350174
Basic UDI-DI: 4560333350001U9
Reference: PROBEAT-LL
EMDN: Z11011001
EMDN description: PROTON THERAPY SYSTEMS
First on market country: Italy
Authorised representative: Hitachi Europe S.A.
Last updated: 04.08.2026 21:29

Manufacturer products Authorised representative products Authorised representative actors View details

05404013851010

Proton Therapy Combined System

Class IIbMDR 2017/745On the market

Manufacturer: Ion Beam Applications SA
Manufacturer SRN: BE-PR-000050794
UDI-DI: 05404013851010
Basic UDI-DI: 54040138IBA-PTC-00PN
Reference: IBA-PTC-00
EMDN: Z11011001
EMDN description: PROTON THERAPY SYSTEMS
First on market country: -
Authorised representative: -
Last updated: 16.07.2026 09:58

Manufacturer products View details

ProteusPLUS

ProteusONE; ProteusPLUS

Class IIbMDR 2017/745Not intended for EU marketActive deviceMeasuring function

Manufacturer: Ion Beam Applications S.A.
Manufacturer SRN: BE-MF-000000818
UDI-DI: 05404013803019
Basic UDI-DI: 54040138IBA-PT-00AJ
Reference: IBA-PT-00-001
EMDN: Z11011001
EMDN description: PROTON THERAPY SYSTEMS
First on market country: -
Authorised representative: -
Last updated: 16.07.2026 09:58

Manufacturer products View details

MEVION S250-FIT Proton Therapy System

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Mevion Medical Systems, Inc.
Manufacturer SRN: US-MF-000008692
UDI-DI: 00864366000117
Basic UDI-DI: 08643660001S250L2
Reference: S250-FIT
EMDN: Z11011001
EMDN description: PROTON THERAPY SYSTEMS
First on market country: Italy
Authorised representative: Regulatory Quality Management Information Source AREU, S.L.U
Last updated: 16.07.2026 06:59

Manufacturer products Authorised representative products Authorised representative actors View details

ProteusONE

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Ion Beam Applications S.A.
Manufacturer SRN: BE-MF-000000818
UDI-DI: 05404013804016
Basic UDI-DI: 54040138IBA-PT-00AJ
Reference: IBA-PT-00-002
EMDN: Z11011001
EMDN description: PROTON THERAPY SYSTEMS
First on market country: -
Authorised representative: -
Last updated: 13.07.2026 23:01

Manufacturer products View details

Mevion S250i

S250i

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: Mevion Medical Systems, Inc.
Manufacturer SRN: US-MF-000008692
UDI-DI: 00864366000124
Basic UDI-DI: B-00864366000124
Reference: S250i
EMDN: Z11011001
EMDN description: PROTON THERAPY SYSTEMS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:49

Manufacturer products Authorised representative products Authorised representative actors View details

ProBeam® Proton Therapy System Fixed Beam Room 4.3

ProBeam, ProBeam 360°