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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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944 device results listed.

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ComboLab AltiX

ComboLab

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278507051
Basic UDI-DI: 8406821BUG00282HJ
Reference: 2300000-005
EMDN: Z12050703
EMDN description: POLYGRAPHY SYSTEMS FOR ELECTROPHYSIOLOGICAL STUDIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

CardioLab AltiX

CardioLab

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278507044
Basic UDI-DI: 8406821BUG00281HG
Reference: 2300000-004
EMDN: Z12050703
EMDN description: POLYGRAPHY SYSTEMS FOR ELECTROPHYSIOLOGICAL STUDIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

Mac-Lab AltiX

Mac-Lab

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278507037
Basic UDI-DI: 8406821BUG00280HE
Reference: 2300000-003
EMDN: Z12050702
EMDN description: POLYGRAPHY SYSTEMS FOR HAEMODYNAMIC STUDIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:51

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: 03.07.2026 12:51

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: 03.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors 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: 03.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

B105P Patient Monitor

B105P

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278488473
Basic UDI-DI: 8406821BUG00323H7
Reference: 6160000-101
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

SIGNA Hero

Class IIaMDR 2017/745On the marketActive deviceContains latex

Manufacturer: GE Medical Systems LLC
Manufacturer SRN: US-MF-000001632
UDI-DI: 00195278486813
Basic UDI-DI: 8406821BUG00278HT
Reference: SIGNA Hero
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 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

VSP 4.0 Upgrade Software

VSP 4.0

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278490742
Basic UDI-DI: 8406821BUG00329HK
Reference: 5877259
EMDN: Z1203020282
EMDN description: MULTI-PARAMETER MONITORS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

MyoSPECT

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems Israel, Functional Imaging
Manufacturer SRN: IL-MF-000003062
UDI-DI: 00195278488619
Basic UDI-DI: 8406821BUG00251H7
Reference: H3912BC
EMDN: Z11020104
EMDN description: FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITHOUT ‘TOTAL BODY’ ACQUISITION
First on market country: Portugal
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:51

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: 03.07.2026 12:51

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: 03.07.2026 12:51

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: 03.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

MUSE NX

Class IIaMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278458070
Basic UDI-DI: 8406821BUG00305H5
Reference: 4101010-002
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

EK12

Starting from V2

Class IIaMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278457547
Basic UDI-DI: 8406821BUG00415HD
Reference: 2104498-003
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

KISS+

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278441874
Basic UDI-DI: 8406821BUG00292HM
Reference: 2093551-100
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

Carestation 650 A1

Carestation 620 A1, Carestation 650 A1, Carestation 650c A1

Class IIbMDR 2017/745On the marketActive deviceAdministering medicine

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000014656
UDI-DI: 00195278439529
Basic UDI-DI: 8406821BUG00403H6
Reference: 1012-9650-200
EMDN: Z1203010101
EMDN description: ANAESTHESIA DEVICES
First on market country: Finland
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

00195278422279

Vivid T8,Vivid T9

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: GE Medical Systems CO. Ltd
Manufacturer SRN: CN-MF-000001856
UDI-DI: 00195278422279
Basic UDI-DI: 8406821BUG00255HF
Reference: Vivid T9 v206/5876948
EMDN: Z11040102
EMDN description: CARDIOLOGY ULTRASOUND SCANNERS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

00195278421388

Vivid iq

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems CO. Ltd
Manufacturer SRN: CN-MF-000001856
UDI-DI: 00195278421388
Basic UDI-DI: 8406821BUG00254HD
Reference: Vivid iq v206/5877072
EMDN: Z11040102
EMDN description: CARDIOLOGY ULTRASOUND SCANNERS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

Portrait CCS01

Portrait Core Services

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278341129
Basic UDI-DI: 8406821BUG00239HH
Reference: 5870857
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 12:50

Manufacturer products Authorised representative products Authorised representative actors View details