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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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SIGNA Creator

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Tianjin Company Limited
Manufacturer SRN: CN-MF-000001725
UDI-DI: 00195278577238
Basic UDI-DI: 8406821BUG00303GZ
Reference: SIGNA Creator
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
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

SIGNA Explorer

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Tianjin Company Limited
Manufacturer SRN: CN-MF-000001725
UDI-DI: 00195278577221
Basic UDI-DI: 8406821BUG00304H3
Reference: SIGNA Explorer
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
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

00195278575814

3.0T 16ch AIR AA

Class IMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Coils
Manufacturer SRN: US-MF-000001664
UDI-DI: 00195278575814
Basic UDI-DI: 8406821BUG00342HB
Reference: 5854101
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
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

Auto Segmentation

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

Voluson SWIFT to BT23 UPG

Voluson SWIFT

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278560124
Basic UDI-DI: 8406821BUG00293HP
Reference: H43222LN
EMDN: Z11040192
EMDN description: ULTRASOUND SCANNERS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
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

Venue Fit R4 UPG

Venue Fit

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
Manufacturer SRN: US-MF-000016119
UDI-DI: 00195278513014
Basic UDI-DI: 8406821BUG00285HQ
Reference: Venue Fit R4 UPG
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
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

00195278503404

Versana Essential

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems CO. Ltd
Manufacturer SRN: CN-MF-000001856
UDI-DI: 00195278503404
Basic UDI-DI: 8406821BUG00287HU
Reference: 5887857
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
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

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

SIGNA 7.0T

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems LLC
Manufacturer SRN: US-MF-000001632
UDI-DI: 00195278483713
Basic UDI-DI: 8406821BUG00299J3
Reference: SIGNA 7.0T
EMDN: Z11050106
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 4T
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

SIGNA Artist Evo

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Tianjin Company Limited
Manufacturer SRN: CN-MF-000001725
UDI-DI: 00195278481382
Basic UDI-DI: 8406821BUG00286HS
Reference: SIGNA Artist Evo
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:26

Manufacturer products Authorised representative products Authorised representative actors View details

00195278466471

5874154

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems CO. Ltd
Manufacturer SRN: CN-MF-000001856
UDI-DI: 00195278466471
Basic UDI-DI: 8406821BUG00296HV
Reference: 5874154
EMDN: Z110402010101
EMDN description: TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:26

Manufacturer products Authorised representative products Authorised representative actors View details

ML4-20-D

ML4-20 probes family

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Parallel Design, Inc.
Manufacturer SRN: US-MF-000009295
UDI-DI: 00195278002723
Basic UDI-DI: 8406821BUG00337HJ
Reference: 5838850
EMDN: Z110402010101
EMDN description: TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:26

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

SPY-PHI Articulating Arm, Table Clamp

AA-0100

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Axcess Surgical Innovations LLC.
Manufacturer SRN: US-MF-000014666
UDI-DI: 00810007560014
Basic UDI-DI: 81000756AXS00016J
Reference: HH1002
EMDN: Z119099
EMDN description: VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Axcess Surgical Innovations B.V.
Last updated: 31.07.2026 22:18

Manufacturer products Authorised representative products Authorised representative actors View details

00195278627056

LOGIQ Fortis

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278627056
Basic UDI-DI: 8406821BUG00214GZ
Reference: LOGIQ Fortis R3 to R4 UPG / 5927390
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:18

Manufacturer products Authorised representative products Authorised representative actors 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