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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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Class IIbMDR 2017/745No longer on the marketActive device

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00195278560384
Basic UDI-DI: 8406821BUG00320GZ
Reference: 591805
EMDN: Z11030692
EMDN description: COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details

Definium Pace Select

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278526892
Basic UDI-DI: 8406821BUG00327HF
Reference: B2604CAB
EMDN: Z11031101
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
First on market country: Romania
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details

OEC Elite MiniView

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278502582
Basic UDI-DI: 8406821BUG00405HA
Reference: 5730328
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:27

Manufacturer products Authorised representative products Authorised representative actors View details

FDX Visionary C

ARCO FP

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: A.T.S. Applicazione Tecnologie Speciali s.r.l.
Manufacturer SRN: IT-MF-000010734
UDI-DI: 08055186670259
Basic UDI-DI: 805518667FPVP
Reference: 74 09 000-1; 74 11 000-1
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 22:22

Manufacturer products View details

FDX Visionary CS

ARCO FP-S

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: A.T.S. Applicazione Tecnologie Speciali s.r.l.
Manufacturer SRN: IT-MF-000010734
UDI-DI: 08055186670167
Basic UDI-DI: 805518667FP-SFH
Reference: 95 01 000; 95 03 000; 95 06 000; 95 08 000
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 22:22

Manufacturer products View details

MCP-MA

Ceiling

Class IMDR 2017/745On the market

Manufacturer: General Medical Merate S.p.A.
Manufacturer SRN: IT-MF-000023169
UDI-DI: 08054890480376
Basic UDI-DI: 805489048PENQ7
Reference: MCP-MA
EMDN: Z11030501
EMDN description: COLUMN STANDS FOR RADIOLOGICAL EQUIPMENT
First on market country: Italy
Authorised representative: -
Last updated: 31.07.2026 22:22

Manufacturer products View details

WST-SX

Wall Stand units

Class IMDR 2017/745On the market

Manufacturer: General Medical Merate S.p.A.
Manufacturer SRN: IT-MF-000023169
UDI-DI: 08054890480161
Basic UDI-DI: 805489048TLRRQ
Reference: WST-SX
EMDN: Z11030506
EMDN description: TELERADIOGRAPHS
First on market country: Italy
Authorised representative: -
Last updated: 31.07.2026 22:22

Manufacturer products View details

Deep Learning Image Reconstruction

ver 1.1, ver 1.2

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Japan Corporation
Manufacturer SRN: JP-MF-000009291
UDI-DI: 00195278620453
Basic UDI-DI: 8406821BUG00032GR
Reference: 5928863
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:18

Manufacturer products Authorised representative products Authorised representative actors View details

Liver Suite

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278547088
Basic UDI-DI: 8406821BUG00114GU
Reference: 5918502
EMDN: Z11030692
EMDN description: COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 22:17

Manufacturer products View details

TrackVision 2

Vision Applications

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278539823
Basic UDI-DI: 8406821BUG00127H5
Reference: 5884028
EMDN: Z11030192
EMDN description: DIGITAL ANGIOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 22:17

Manufacturer products View details

Spine Auto Views

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278534064
Basic UDI-DI: 8406821BUG00201GQ
Reference: 5914361
EMDN: Z11030692
EMDN description: COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 22:17

Manufacturer products View details

Revolution Apex Plus

Revolution

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00195278502179
Basic UDI-DI: 8406821BUG00014GP
Reference: 5590000-25
EMDN: Z11030607
EMDN description: COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

CardIQ Suite

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278498649
Basic UDI-DI: 8406821BUG00217H7
Reference: 5882923
EMDN: Z11030692
EMDN description: COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 22:17

Manufacturer products View details

Performix Pulsar

Performix

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000001861
UDI-DI: 00195278494542
Basic UDI-DI: 8406821BUG00243H8
Reference: 5886600
EMDN: Z11039012
EMDN description: X-RAY TUBE ASSEMBLY
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

IGS 5

Allia

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278485144
Basic UDI-DI: 8406821BUG00099HR
Reference: 5872892
EMDN: Z11030102
EMDN description: STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 22:17

Manufacturer products View details

Revolution CT ES with Apex edition

Apex Edition

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00195278471277
Basic UDI-DI: 8406821BUG00154H8
Reference: Revolution CT ES with Apex edition
EMDN: Z11030607
EMDN description: COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

Revolution Apex Select

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN: CN-MF-000009292
UDI-DI: 00195278469700
Basic UDI-DI: 8406821BUG00213GX
Reference: Power Xtream: B7919QT; Power Pro: B7919QS
EMDN: Z11030606
EMDN description: COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS
First on market country: Belgium
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

RT Refresh Package

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN: CN-MF-000009292
UDI-DI: 00195278466488
Basic UDI-DI: 8406821BUG00215H3
Reference: B79612DA, B79602DA
EMDN: Z11030603
EMDN description: COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

Definium Tempo

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278118356
Basic UDI-DI: 8406821BUG00192HG
Reference: B2401CAB
EMDN: Z11031101
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

Definium Tempo Pro

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278070265
Basic UDI-DI: 8406821BUG00193HJ
Reference: B2402CAB
EMDN: Z11031101
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details