Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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17.07.2026 05:10

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948 device results listed.

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Aurora

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00198953017616
Basic UDI-DI: 08406821BUG005717G
Reference: H2412AL, H2412AN
EMDN: Z11020201
EMDN description: CT/GAMMA CAMERA SYSTEMS
First on market country: Ireland
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:57

Manufacturer products Authorised representative products Authorised representative actors View details

Omni

PCM-PET0014

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Israel, Functional Imaging
Manufacturer SRN: IL-MF-000003062
UDI-DI: 00198953006849
Basic UDI-DI: 08406821BUG005727J
Reference: PCM-PET0014
EMDN: Z11020301
EMDN description: CT/PET SYSTEMS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:57

Manufacturer products Authorised representative products Authorised representative actors View details

4Sc-RS

5973383

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems CO. Ltd
Manufacturer SRN: CN-MF-000001856
UDI-DI: 00195278985613
Basic UDI-DI: 08406821BUG005927Q
Reference: H48062AU
EMDN: Z110402010301
EMDN description: TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:57

Manufacturer products Authorised representative products Authorised representative actors View details

L8-18t-RS

5943098

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems CO. Ltd
Manufacturer SRN: CN-MF-000001856
UDI-DI: 00195278938886
Basic UDI-DI: 08406821BUG006347F
Reference: 5943098, H48062AT
EMDN: Z110402010101
EMDN description: TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:57

Manufacturer products Authorised representative products Authorised representative actors View details

SIGNA Sprint

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Tianjin Company Limited
Manufacturer SRN: CN-MF-000001725
UDI-DI: 00195278929518
Basic UDI-DI: 08406821BUG0052579
Reference: SIGNA Sprint
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
First on market country: Belgium
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:57

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Revolution Maxima

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN: CN-MF-000009292
UDI-DI: 00195278923257
Basic UDI-DI: 08406821BUG004907F
Reference: Revolution Maxima
EMDN: Z11030606
EMDN description: COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:57

Manufacturer products Authorised representative products Authorised representative actors View details

MAC 3

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278921628
Basic UDI-DI: 08406821BUG0050573
Reference: 3048726-001
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Germany
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:57

Manufacturer products Authorised representative products Authorised representative actors View details

00195278913814

Definium Tempo Select

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278913814
Basic UDI-DI: 08406821BUG005197E
Reference: B2400UDI
EMDN: Z11031101
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

00195278913807

Definium Pace Select ET

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278913807
Basic UDI-DI: 08406821BUG005206X
Reference: B2600UDI
EMDN: Z11031101
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

Voluson Performance 16

Voluson Performance 18, Voluson Performance 16

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278910493
Basic UDI-DI: 08406821BUG005126Y
Reference: Voluson Performance 16 / 5957171
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

CARESCAPE Gateway

5697315-002

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278888235
Basic UDI-DI: 08406821BUG005287F
Reference: 5697315-002
EMDN: Z1203020292
EMDN description: MULTI-PARAMETER MONITORS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

Console Generation Upgrade

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN: CN-MF-000009292
UDI-DI: 00195278882677
Basic UDI-DI: 08406821BUG004897W
Reference: Console Generation Upgrade
EMDN: Z11030606
EMDN description: COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS
First on market country: Spain
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

Carevance D7

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems CO. Ltd
Manufacturer SRN: CN-MF-000001856
UDI-DI: 00195278878724
Basic UDI-DI: 08406821BUG005867V
Reference: 8180008
EMDN: Z1203020280
EMDN description: MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

Carevance D12

Carevance D12 Carevance D15 Carevance D19

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems CO. Ltd
Manufacturer SRN: CN-MF-000001856
UDI-DI: 00195278878670
Basic UDI-DI: 08406821BUG005857T
Reference: 8180000-001
EMDN: Z1203020280
EMDN description: MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

Carevance H1

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems CO. Ltd
Manufacturer SRN: CN-MF-000001856
UDI-DI: 00195278878663
Basic UDI-DI: 08406821BUG005847R
Reference: 8180000-010
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

Aurora

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Israel, Functional Imaging
Manufacturer SRN: IL-MF-000003062
UDI-DI: 00195278878502
Basic UDI-DI: 08406821BUG004817E
Reference: Aurora-NM-PCM
EMDN: Z11020201
EMDN description: CT/GAMMA CAMERA SYSTEMS
First on market country: Denmark
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

Carestation 850

Carestation 850, Carestation 850c

Class IIbMDR 2017/745On the marketActive deviceAdministering medicineCMR substance

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000014656
UDI-DI: 00195278843593
Basic UDI-DI: 08406821BUG005367E
Reference: 1012-9850-000
EMDN: Z1203010101
EMDN description: ANAESTHESIA DEVICES
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

Revolution RT

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN: CN-MF-000009292
UDI-DI: 00195278809810
Basic UDI-DI: 08406821BUG004947P
Reference: B81912DA, B7590AE
EMDN: Z11030603
EMDN description: COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS
First on market country: Germany
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

Venue Sprint

Venue Sprint R5

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: 00195278754011
Basic UDI-DI: 08406821BUG004887U
Reference: Venue Sprint R5
EMDN: Z11040192
EMDN description: ULTRASOUND SCANNERS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

6Sc-D

5890308

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Healthcare Japan Corporation
Manufacturer SRN: JP-MF-000009291
UDI-DI: 00195278723963
Basic UDI-DI: 08406821BUG004827G
Reference: H46462LS
EMDN: Z110402010301
EMDN description: TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details