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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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955 device results listed.

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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: 31.07.2026 22:17

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: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

Revolution Apex Plus

Revolution

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00195278502179
Basic UDI-DI: 8406821BUG00014GP
Reference: 5590000-25
EMDN: Z11030607
EMDN description: COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

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: 31.07.2026 22:17

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: 31.07.2026 22:17

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00195278488527

Vivid iq

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems CO. Ltd
Manufacturer SRN: CN-MF-000001856
UDI-DI: 00195278488527
Basic UDI-DI: 8406821BUG00254HD
Reference: Vivid iq v204 to v206 UPG SW only/5886276
EMDN: Z11040102
EMDN description: CARDIOLOGY ULTRASOUND SCANNERS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

00195278487414

LOGIQ E10s

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278487414
Basic UDI-DI: 8406821BUG00033GT
Reference: LOGIQ E10s R2 to R3 UPG / 5874847
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

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: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

00195278473028

Voluson S10 Expert, Voluson S10, Voluson S8t, Voluson S8, Voluson S6

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278473028
Basic UDI-DI: 8406821BUG00209H8
Reference: Voluson Signature to BT22 UPG / 5881172
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

00195278473011

Voluson P8, Voluson P6

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278473011
Basic UDI-DI: 8406821BUG00210GR
Reference: Voluson Performance to BT22 UPG / 5881175
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

Revolution CT ES with Apex edition

Apex Edition

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00195278471277
Basic UDI-DI: 8406821BUG00154H8
Reference: Revolution CT ES with Apex edition
EMDN: Z11030607
EMDN description: COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

Revolution Apex Select

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN: CN-MF-000009292
UDI-DI: 00195278469700
Basic UDI-DI: 8406821BUG00213GX
Reference: Power Xtream: B7919QT; Power Pro: B7919QS
EMDN: Z11030606
EMDN description: COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS
First on market country: Belgium
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

RT Refresh Package

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN: CN-MF-000009292
UDI-DI: 00195278466488
Basic UDI-DI: 8406821BUG00215H3
Reference: B79612DA, B79602DA
EMDN: Z11030603
EMDN description: COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

00195278464668

LOGIQ P8, LOGIQ P9, LOGIQ P10

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278464668
Basic UDI-DI: 8406821BUG00211GT
Reference: LOGIQ P10 R4.5 HD/H42932LE
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Spain
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:17

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: 31.07.2026 22:17

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: 31.07.2026 22:17

Manufacturer products Authorised representative products Authorised representative actors View details

ML4-20VN-D

Class IIaNot specifiedOn 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: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

Spectral Bone Marrow

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00195278630377
Basic UDI-DI: 8406821BUG00412H7
Reference: 5929650
EMDN: Z11030692
EMDN description: COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

Spectral Color Overlay

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00195278630384
Basic UDI-DI: 8406821BUG00413H9
Reference: 5929649
EMDN: Z11030692
EMDN description: COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

Revolution Apex Expert

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN: CN-MF-000009292
UDI-DI: 00195278633149
Basic UDI-DI: 8406821BUG00213GX
Reference: Revolution Apex Expert
EMDN: Z11030606
EMDN description: COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS
First on market country: -
Authorised representative: GE Medical Systems SCS
Last updated: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details