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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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967 device results listed.

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NM/CT 860

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Israel, Functional Imaging
Manufacturer SRN: IL-MF-000003062
UDI-DI: 00198953061329
Basic UDI-DI: 08406821BUG004717B
Reference: H3908BF, H3908BG, H3908BK, H3908BL, H3908BM, H3908BN
EMDN: Z11020201
EMDN description: CT/GAMMA CAMERA 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

Serenity S Vaporizer GEHC SEV Easy-Fil EN-UK

Serenity S, Serenity T

Class IIbMDR 2017/745On the marketActive deviceAdministering medicineCMR substance

Manufacturer: Datex-Ohmeda Inc.
Manufacturer SRN: US-MF-000014656
UDI-DI: 00198953043844
Basic UDI-DI: 08406821BUG004777P
Reference: SS22G01NN07
EMDN: Z1203010180
EMDN description: ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES
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

SnapShot Freeze

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00198953050996
Basic UDI-DI: 08406821BUG005937S
Reference: 5987386
EMDN: Z11030692
EMDN description: COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:57

Manufacturer products Authorised representative products Authorised representative actors View details

00198953043455

LOGIQ Focus X R1, LOGIQ Focus S R1,

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems CO. Ltd
Manufacturer SRN: CN-MF-000001856
UDI-DI: 00198953043455
Basic UDI-DI: 08406821BUG006327B
Reference: 5984527
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
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

00198953043387

MR Contour DL

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare
Manufacturer SRN: US-MF-000001862
UDI-DI: 00198953043387
Basic UDI-DI: 08406821BUG0059782
Reference: 5986345-001
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
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

CareIntellect MUSE

Class IIaMDR 2017/745On the market

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00198953041741
Basic UDI-DI: 08406821BUG005807H
Reference: 5970545-001
EMDN: Z12050392
EMDN description: ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE
First on market country: Italy
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:57

Manufacturer products Authorised representative products Authorised representative actors View details

Caption Interpretation

5700636

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
Manufacturer SRN: US-MF-000016119
UDI-DI: 00198953038284
Basic UDI-DI: 08406821BUG005487M
Reference: 5700636
EMDN: Z11040182
EMDN description: ULTRASOUND SCANNERS - SOFTWARE ACCESSORIES
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:57

Manufacturer products Authorised representative products Authorised representative actors View details

Caption AI

5700645

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
Manufacturer SRN: US-MF-000016119
UDI-DI: 00198953030233
Basic UDI-DI: 08406821BUG005477K
Reference: 5984922
EMDN: Z11040182
EMDN description: ULTRASOUND SCANNERS - SOFTWARE ACCESSORIES
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:57

Manufacturer products Authorised representative products Authorised representative actors View details

Revolution Altitude Plus

Revolution Altitude Family

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN: CN-MF-000009292
UDI-DI: 00198953018989
Basic UDI-DI: 08406821BUG0060578
Reference: Revolution Altitude Plus
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

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

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

SIGNA Prime Elite

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Tianjin Company Limited
Manufacturer SRN: CN-MF-000001725
UDI-DI: 00195278601162
Basic UDI-DI: 08406821BUG004837J
Reference: SIGNA Prime Elite
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
First on market country: Türkiye
Authorised representative: GE Medical Systems SCS
Last updated: 16.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

Revolution Advance

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN: CN-MF-000009292
UDI-DI: 00195278385215
Basic UDI-DI: 08406821BUG005116W
Reference: Revolution Advance
EMDN: Z11030603
EMDN description: COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS
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

00195278464675

Class IIaNot specifiedOn the marketActive device

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278464675
Basic UDI-DI: 8406821BUG00211GT
Reference: LP9 R4 to R4.5 SW Conversion/H43012LF
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 14.07.2026 07:58

Manufacturer products Authorised representative products Authorised representative actors View details

Voluson S10 Expert

Class IIaNot specifiedOn the marketActive deviceMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278473042
Basic UDI-DI: 8406821BUG00209H8
Reference: Voluson S10 Expert BT22 / 5880987
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 14.07.2026 07:58

Manufacturer products Authorised representative products Authorised representative actors View details

Voluson S10

Class IIaNot specifiedOn the marketActive deviceMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278473059
Basic UDI-DI: 8406821BUG00209H8
Reference: Voluson S10 BT22 / 5880998
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 14.07.2026 07:58

Manufacturer products Authorised representative products Authorised representative actors View details