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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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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

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: 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

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: 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

SOFT-CUF, SMALL ADULT, DINACLICK, 17 - 25 CM, ENG., 80369-5, SINGLE

Soft-Cuf Non-Invasive Blood Pressure Cuff

Class IMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278025319
Basic UDI-DI: 8406821BUG00034GV
Reference: 5855267
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

CLASSIC-CUF ISO, INFANT, DINACLICK, 08 - 13 CM, 80369-5, SINGLE

Classic-Cuf Non-Invasive Blood Pressure Cuff

Class IMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278025272
Basic UDI-DI: 8406821BUG00035GX
Reference: 5855221
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

SIGNA Architect

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems LLC
Manufacturer SRN: US-MF-000001632
UDI-DI: 00195278023643
Basic UDI-DI: 8406821BUG00003GJ
Reference: SIGNA Architect
EMDN: Z11050105
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T
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

Unity Network ID

Class IMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278017949
Basic UDI-DI: 8406821BUG00030GM
Reference: 5514403
EMDN: Z12030299
EMDN description: VITAL SIGNS MONITORING INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:40

Manufacturer products Authorised representative products Authorised representative actors View details

SIGNA Premier

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems LLC
Manufacturer SRN: US-MF-000001632
UDI-DI: 00195278010797
Basic UDI-DI: 8406821BUG00092HB
Reference: SIGNA Premier
EMDN: Z11050105
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T
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 Pioneer

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems LLC
Manufacturer SRN: US-MF-000001632
UDI-DI: 00195278005502
Basic UDI-DI: 8406821BUG00093HD
Reference: SIGNA Pioneer
EMDN: Z11050105
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T
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

ML4-20VN-D

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Parallel Design, Inc.
Manufacturer SRN: US-MF-000009295
UDI-DI: 00195278002730
Basic UDI-DI: 8406821BUG00337HJ
Reference: 5838851
EMDN: Z110402010101
EMDN description: TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 29.06.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details