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

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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: 03.07.2026 12:43

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: 03.07.2026 12:43

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: 03.07.2026 12:43

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: 03.07.2026 12:43

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: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

00195278464613

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: 00195278464613
Basic UDI-DI: 8406821BUG00211GT
Reference: LOGIQ P8 R4.5/H42932LB
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Spain
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Revolution Apex Elite

Revolution

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00195278460271
Basic UDI-DI: 8406821BUG00014GP
Reference: 5590000-23
EMDN: Z11030607
EMDN description: COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE
First on market country: Denmark
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Omni Legend

Class IIbMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems, LLC
Manufacturer SRN: US-MF-000018315
UDI-DI: 00195278454218
Basic UDI-DI: 8406821BUG00208H6
Reference: PCM-PET0012
EMDN: Z11020301
EMDN description: CT/PET SYSTEMS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

00195278421449

CAM-14

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278421449
Basic UDI-DI: 8406821BUG00183HF
Reference: 900995-102
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

1.5T HDxt Upgrade Kit

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems LLC
Manufacturer SRN: US-MF-000001632
UDI-DI: 00195278416339
Basic UDI-DI: 8406821BUG00105GT
Reference: 1.5T HDxt Upgrade Kit
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 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

00195278410221

LOGIQ E10s

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278410221
Basic UDI-DI: 8406821BUG00033GT
Reference: 5860223
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Enterprise Archive v8

Centricity Enterprise Archive / Enterprise Archive

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE Healthcare
Manufacturer SRN: US-MF-000001862
UDI-DI: 00195278409287
Basic UDI-DI: 8406821BUG00019GZ
Reference: 5865732
EMDN: Z11030592
EMDN description: RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

00195278405326

LOGIQ Fortis

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Ultrasound Korea, Ltd.
Manufacturer SRN: KR-MF-000001860
UDI-DI: 00195278405326
Basic UDI-DI: 8406821BUG00214GZ
Reference: 6602000
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Austria
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

CASE

CASE V7.0

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278403643
Basic UDI-DI: 8406821BUG00170H6
Reference: 2035123-001
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

LOGIQ E10

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
Manufacturer SRN: US-MF-000016119
UDI-DI: 00195278384041
Basic UDI-DI: 8406821BUG00028H2
Reference: 5935000E10-3
EMDN: Z11040104
EMDN description: MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

00195278363947

MaxFOV 2

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN: CN-MF-000009292
UDI-DI: 00195278363947
Basic UDI-DI: 8406821BUG00175HG
Reference: MaxFOV 2
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 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Revolution Frontier

Revolution Frontier Gen 3_HD Refresh Package

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN: CN-MF-000009292
UDI-DI: 00195278362230
Basic UDI-DI: 8406821BUG00202GS
Reference: Revolution Frontier
EMDN: Z11030605
EMDN description: COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiosoft

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278364661
Basic UDI-DI: 8406821BUG00157HE
Reference: 2032557-001, 2032558-001, 2032559-001
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 03.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

CARESCAPE Central Station

Version 3

Class IIbMDR 2017/745On the marketDirect marking

Manufacturer: GE Medical Systems Information Technologies, Inc.
Manufacturer SRN: US-MF-000017529
UDI-DI: 00195278343383
Basic UDI-DI: 8406821BUG00160H3
Reference: 5867474-03
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 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

SmartMAR

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Japan Corporation
Manufacturer SRN: JP-MF-000009291
UDI-DI: 00195278303219
Basic UDI-DI: 8406821BUG00156HC
Reference: 5869274
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 12:42

Manufacturer products Authorised representative products Authorised representative actors View details