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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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948 device results listed.

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1.5T HDxt Upgrade Kit

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems LLC
Manufacturer SRN: US-MF-000001632
UDI-DI: 00195278416339
Basic UDI-DI: 8406821BUG00105GT
Reference: 1.5T HDxt Upgrade Kit
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: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

00195278410221

LOGIQ E10s

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278410221
Basic UDI-DI: 8406821BUG00033GT
Reference: 5860223
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Enterprise Archive v8

Centricity Enterprise Archive / Enterprise Archive

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Healthcare
Manufacturer SRN: US-MF-000001862
UDI-DI: 00195278409287
Basic UDI-DI: 8406821BUG00019GZ
Reference: 5865732
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

00195278405326

LOGIQ Fortis

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278405326
Basic UDI-DI: 8406821BUG00214GZ
Reference: 6602000
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

CASE

CASE V7.0

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278403643
Basic UDI-DI: 8406821BUG00170H6
Reference: 2035123-001
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

LOGIQ E10

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
Manufacturer SRN: US-MF-000016119
UDI-DI: 00195278384041
Basic UDI-DI: 8406821BUG00028H2
Reference: 5935000E10-3
EMDN: Z11040104
EMDN description: MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

00195278363947

MaxFOV 2

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN: CN-MF-000009292
UDI-DI: 00195278363947
Basic UDI-DI: 8406821BUG00175HG
Reference: MaxFOV 2
EMDN: Z11030692
EMDN description: COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Revolution Frontier

Revolution Frontier Gen 3_HD Refresh Package

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN: CN-MF-000009292
UDI-DI: 00195278362230
Basic UDI-DI: 8406821BUG00202GS
Reference: Revolution Frontier
EMDN: Z11030605
EMDN description: COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiosoft

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278364661
Basic UDI-DI: 8406821BUG00157HE
Reference: 2032557-001, 2032558-001, 2032559-001
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

CARESCAPE Central Station

Version 3

Class IIbMDR 2017/745On the marketDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278343383
Basic UDI-DI: 8406821BUG00160H3
Reference: 5867474-03
EMDN: Z1203020292
EMDN description: MULTI-PARAMETER MONITORS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

SmartMAR

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Japan Corporation
Manufacturer SRN: JP-MF-000009291
UDI-DI: 00195278303219
Basic UDI-DI: 8406821BUG00156HC
Reference: 5869274
EMDN: Z11030692
EMDN description: COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

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: 00195278303202
Basic UDI-DI: 8406821BUG00032GR
Reference: 5869275
EMDN: Z11030692
EMDN description: COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

ASiR-V

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Japan Corporation
Manufacturer SRN: JP-MF-000009291
UDI-DI: 00195278303196
Basic UDI-DI: 8406821BUG00155HA
Reference: 5869273
EMDN: Z11030692
EMDN description: COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

00195278300034

Versana Balance

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems CO. Ltd
Manufacturer SRN: CN-MF-000001856
UDI-DI: 00195278300034
Basic UDI-DI: 8406821BUG00204GW
Reference: 5868333
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

CARESCAPE One

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278288639
Basic UDI-DI: 8406821BUG00161H5
Reference: 2087075-300
EMDN: Z1203020202
EMDN description: TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

DV GOC Upgrade Console

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems LLC
Manufacturer SRN: US-MF-000001632
UDI-DI: 00195278229519
Basic UDI-DI: 8406821BUG00150GY
Reference: DV GOC Upgrade Console
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: 03.07.2026 12:40

Manufacturer products Authorised representative products Authorised representative actors View details

SIGNA Voyager

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Tianjin Company Limited
Manufacturer SRN: CN-MF-000001725
UDI-DI: 00195278124609
Basic UDI-DI: 8406821BUG00101GK
Reference: SIGNA Voyager
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: 03.07.2026 12:40

Manufacturer products Authorised representative products Authorised representative actors View details

SIGNA Artist

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Tianjin Company Limited
Manufacturer SRN: CN-MF-000001725
UDI-DI: 00195278117021
Basic UDI-DI: 8406821BUG00098HP
Reference: SIGNA Artist
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: 03.07.2026 12:40

Manufacturer products Authorised representative products Authorised representative actors View details

Discovery MI Gen2

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00195278098603
Basic UDI-DI: 8406821BUG00159HJ
Reference: PCM-PET0009
EMDN: Z11020301
EMDN description: CT/PET SYSTEMS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:40

Manufacturer products Authorised representative products Authorised representative actors View details

SOFT-CUF, RADIAL, DINACLICK, 26 - 36 CM, 80369-5, SINGLE

Radial-Cuf

Class IMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278025562
Basic UDI-DI: 8406821BUG00038H5
Reference: 5855310
EMDN: Z12040180
EMDN description: GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:40

Manufacturer products Authorised representative products Authorised representative actors View details