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58 device results listed.

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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

FCT iStream

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04573596204382
Basic UDI-DI: 45735962010100000000001Y8
Reference: FCT iStream
EMDN: Z11030606
EMDN description: COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 06:11

Manufacturer products Authorised representative products Authorised representative actors View details

SCENARIA View

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04573596200544
Basic UDI-DI: 457359620X-ray_CTZU
Reference: SCENARIA View
EMDN: Z11030606
EMDN description: COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 06:09

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

Revolution Ascend Elite

Revolution Ascend, Revolution Ascend Elite, Revolution Ascend Plus, Revolution Ascend Select

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Healthcare Japan Corporation
Manufacturer SRN: JP-MF-000009291
UDI-DI: 00195278718129
Basic UDI-DI: 8406821BUG00117H2
Reference: Revolution Ascend Elite
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: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

Revolution Ascend Plus

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Healthcare Japan Corporation
Manufacturer SRN: JP-MF-000009291
UDI-DI: 00195278718136
Basic UDI-DI: 8406821BUG00117H2
Reference: Revolution Ascend Plus
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

Revolution Ascend Select

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE Healthcare Japan Corporation
Manufacturer SRN: JP-MF-000009291
UDI-DI: 00195278718204
Basic UDI-DI: 8406821BUG00117H2
Reference: Revolution Ascend Select
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

Revolution Apex Select with Plus Edition

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: GE HANGWEI MEDICAL SYSTEMS CO., LTD.
Manufacturer SRN: CN-MF-000009292
UDI-DI: 00195278788665
Basic UDI-DI: 8406821BUG00213GX
Reference: Revolution Apex Select with Plus Edition
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

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: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

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: 30.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

SOMATOM X.cite

MDR_03_II b_FOR S3_CT_Scanner

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthineers AG
Manufacturer SRN: DE-MF-000038456
UDI-DI: 04068151994995
Basic UDI-DI: 0405686902298W6
Reference: 11330001
EMDN: Z11030606
EMDN description: COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 18:29

Manufacturer products View details

06938964326017

TurboTom 5 PRO

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Beijing Wandong Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014174
UDI-DI: 06938964326017
Basic UDI-DI: 693896432600P2
Reference: N/A
EMDN: Z11030606
EMDN description: COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:38

Manufacturer products Authorised representative products Authorised representative actors View details

CT Rembra

CT Scanner System (CT Rembra RT/CT Areta RT/CT Rembra)

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000003923
UDI-DI: 00884838129528
Basic UDI-DI: 0884838BM1701ME
Reference: 728383
EMDN: Z11030606
EMDN description: COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS
First on market country: Netherlands
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:13

Manufacturer products Authorised representative products Authorised representative actors View details

Incisive CT

CT Scanner System (Incisive CT/CT5300)

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000003923
UDI-DI: 00884838085015
Basic UDI-DI: 0884838BM285T6
Reference: 728143
EMDN: Z11030606
EMDN description: COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS
First on market country: Netherlands
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 16.07.2026 07:11

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

SOMATOM Definition AS

CT-Scanner_IIb_ERLN H 127

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Siemens Healthcare GmbH
Manufacturer SRN: DE-MF-000006122
UDI-DI: 04056869003665
Basic UDI-DI: 0405686900117UR
Reference: 08098027
EMDN: Z11030606
EMDN description: COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:10

Manufacturer products View details

Optima CT660

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: GE Healthcare Japan Corporation
Manufacturer SRN: JP-MF-000009291
UDI-DI: D-OptimaCT660WA
Basic UDI-DI: B-OptimaCT660WA
Reference: Optima CT660
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: 14.07.2026 06:15

Manufacturer products Authorised representative products Authorised representative actors View details

06971576831050

uCT 780

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: Shanghai United Imaging Healthcare Co.,Ltd.
Manufacturer SRN: CN-MF-000008501
UDI-DI: 06971576831050
Basic UDI-DI: B-06971576831050
Reference: 80513129
EMDN: Z11030606
EMDN description: COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS
First on market country: Poland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

06971576831043

uCT 760

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: Shanghai United Imaging Healthcare Co.,Ltd.
Manufacturer SRN: CN-MF-000008501
UDI-DI: 06971576831043
Basic UDI-DI: B-06971576831043
Reference: 80000063
EMDN: Z11030606
EMDN description: COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS
First on market country: Poland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

Revolution EVO

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: GE Healthcare Japan Corporation
Manufacturer SRN: JP-MF-000009291
UDI-DI: 00840682109796
Basic UDI-DI: B-00840682109796
Reference: Revolution EVO
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: 05.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details