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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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05.07.2026 16:34

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944 device results listed.

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RAB7-D

5929364

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems CO. Ltd
Manufacturer SRN: CN-MF-000001856
UDI-DI: 00195278644152
Basic UDI-DI: 8406821BUG00350HA
Reference: H48062AN
EMDN: Z110402010202
EMDN description: CURVILINEAR TRANSCUTANEOUS MULTIDIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY)
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

Voluson Signature 20

Voluson Signature 20, Voluson Signature 18

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278633804
Basic UDI-DI: 8406821BUG00309HD
Reference: Voluson Signature 20 / 5926010
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:52

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: 03.07.2026 12:52

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: 03.07.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

Head Auto Views

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00195278629586
Basic UDI-DI: 8406821BUG00411H5
Reference: 5929651
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 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

Xeleris V Processing & Review System

Xeleris V Processing and Review System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Israel, Functional Imaging
Manufacturer SRN: IL-MF-000003062
UDI-DI: 00195278614933
Basic UDI-DI: 8406821BUG00344HF
Reference: 5927911
EMDN: Z11069092
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAC 7 Resting ECG Analysis System

MAC 7

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278620873
Basic UDI-DI: 8406821BUG00386HX
Reference: 2119091-001
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

SIGNA Victor

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Tianjin Company Limited
Manufacturer SRN: CN-MF-000001725
UDI-DI: 00195278616845
Basic UDI-DI: 8406821BUG00328HH
Reference: SIGNA Victor
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 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

Quality Care Suite 2.0

Quality Care Suite

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00195278584441
Basic UDI-DI: 8406821BUG00407HE
Reference: S3003CV, S3003EV
EMDN: Z11039092
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

SIGNA Creator

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Tianjin Company Limited
Manufacturer SRN: CN-MF-000001725
UDI-DI: 00195278577238
Basic UDI-DI: 8406821BUG00303GZ
Reference: SIGNA Creator
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 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

SIGNA Explorer

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Tianjin Company Limited
Manufacturer SRN: CN-MF-000001725
UDI-DI: 00195278577221
Basic UDI-DI: 8406821BUG00304H3
Reference: SIGNA Explorer
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 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

00195278575814

3.0T 16ch AIR AA

Class IMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Coils
Manufacturer SRN: US-MF-000001664
UDI-DI: 00195278575814
Basic UDI-DI: 8406821BUG00342HB
Reference: 5854101
EMDN: Z1105018001
EMDN description: MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

Portrait VSM

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278561312
Basic UDI-DI: 8406821BUG00384HT
Reference: 6660000-666
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 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Segmentation

Class IIbMDR 2017/745No longer on the marketActive device

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00195278560384
Basic UDI-DI: 8406821BUG00320GZ
Reference: 591805
EMDN: Z11030692
EMDN description: COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

Voluson SWIFT to BT23 UPG

Voluson SWIFT

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278560124
Basic UDI-DI: 8406821BUG00293HP
Reference: H43222LN
EMDN: Z11040192
EMDN description: ULTRASOUND SCANNERS - MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

Definium Pace Select

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE HUALUN MEDICAL SYSTEMS CO. Ltd
Manufacturer SRN: CN-MF-000001189
UDI-DI: 00195278526892
Basic UDI-DI: 8406821BUG00327HF
Reference: B2604CAB
EMDN: Z11031101
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
First on market country: Romania
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

Venue Go

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: 00195278516510
Basic UDI-DI: 8406821BUG00284HN
Reference: Venue Go R4
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

Venue Fit R4 UPG

Venue Fit

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: 00195278513014
Basic UDI-DI: 8406821BUG00285HQ
Reference: Venue Fit R4 UPG
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

CARESCAPE PDM (Patient Data Module)

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278510747
Basic UDI-DI: 8406821BUG00298HZ
Reference: 5863573
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 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

MLCL Client Software AltiX

MLCL Client Software

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278507525
Basic UDI-DI: 8406821BUG00301GV
Reference: 5889605
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