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

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SENSE Head Coil 1.5T/8ch

Class IIaMDDOn the marketActive device

Manufacturer: Invivo Corporation
Manufacturer SRN: US-MF-000002284
UDI-DI: 00884838065659
Basic UDI-DI: B-00884838065659
Reference: 453530057613
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Netherlands
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 01.08.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details

dS FLEX-L 1.5T

Class IIaMDDOn the marketActive device

Manufacturer: Invivo Corporation
Manufacturer SRN: US-MF-000002284
UDI-DI: 00884838065598
Basic UDI-DI: B-00884838065598
Reference: 453530322314
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Netherlands
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 01.08.2026 20:48

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dS FLEX-S 1.5T

Class IIaMDDOn the marketActive device

Manufacturer: Invivo Corporation
Manufacturer SRN: US-MF-000002284
UDI-DI: 00884838065581
Basic UDI-DI: B-00884838065581
Reference: 453530322335
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Netherlands
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 01.08.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details

DS FLEX-M 3.0T

Class IIaMDDOn the marketActive device

Manufacturer: Invivo Corporation
Manufacturer SRN: US-MF-000002284
UDI-DI: 00884838065574
Basic UDI-DI: B-00884838065574
Reference: 453530322425
EMDN: Z1105018099
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER
First on market country: Netherlands
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 01.08.2026 20:48

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: 31.07.2026 22:27

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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: 31.07.2026 22:27

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: 31.07.2026 22:27

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: 31.07.2026 22:27

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SIGNA 7.0T

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Medical Systems LLC
Manufacturer SRN: US-MF-000001632
UDI-DI: 00195278483713
Basic UDI-DI: 8406821BUG00299J3
Reference: SIGNA 7.0T
EMDN: Z11050106
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 4T
First on market country: France
Authorised representative: GE Medical Systems SCS
Last updated: 31.07.2026 22:27

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SIGNA Artist Evo

Class IIaMDR 2017/745On the marketActive device

Manufacturer: GE Healthcare Tianjin Company Limited
Manufacturer SRN: CN-MF-000001725
UDI-DI: 00195278481382
Basic UDI-DI: 8406821BUG00286HS
Reference: SIGNA Artist Evo
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: 31.07.2026 22:26

Manufacturer products Authorised representative products Authorised representative actors View details

READY View

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: GE Medical Systems SCS
Manufacturer SRN: FR-MF-000000687
UDI-DI: 00195278510600
Basic UDI-DI: 8406821BUG00080H4
Reference: 5890197
EMDN: Z11050192
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 22:17

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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

06938964329018

i_Space 1.5T, i_Space 1.5T Plus, i_Space 1.5T Pro, i_Field 1.5T, i_Field 1.5T Plus, i_Field 1.5T Pro, i_Scope, i_Scope X, i_Scope XT

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Beijing Wandong Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014174
UDI-DI: 06938964329018
Basic UDI-DI: 693896432800PC
Reference: N/A
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:10

Manufacturer products Authorised representative products Authorised representative actors View details

06938964322125

i_Vision 1.5T Plus, i_Vision 1.5T, i_Vision 1.5T Pro, i_Vision70 1.5T, i_Vision70 1.5T Plus, i_Vision70 1.5T Pro

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Beijing Wandong Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014174
UDI-DI: 06938964322125
Basic UDI-DI: 693896432200NE
Reference: N/A
EMDN: Z11050104
EMDN description: CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:10

Manufacturer products Authorised representative products Authorised representative actors View details

06938964321012

i_Open 0.3T, i_Open 0.36T, i_Open 0.4T, i_Open 0.5T

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Beijing Wandong Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014174
UDI-DI: 06938964321012
Basic UDI-DI: 693896432100N9
Reference: N/A
EMDN: Z11050102
EMDN description: OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:10

Manufacturer products Authorised representative products Authorised representative actors View details

APERTO Lucent

Class IIaMDR 2017/745On the marketContains latex

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04573596200711
Basic UDI-DI: 457359620103000000000052V
Reference: APERTO Lucent
EMDN: Z11050102
EMDN description: OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

AIRIS Vento

Class IIaMDR 2017/745On the marketContains latex

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04573596200674
Basic UDI-DI: 457359620103000000000032R
Reference: AIRIS Vento
EMDN: Z11050102
EMDN description: OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

RöKo-Filling-Line 1

Kontrastmittel-Applikations-Set 12h

Class IIaMDR 2017/745On the marketSterile

Manufacturer: CARDEA GmbH & Co. KG
Manufacturer SRN: DE-MF-000006460
UDI-DI: 04260590630032
Basic UDI-DI: 426059063000002AA
Reference: rkp-FL-1
EMDN: Z11050185
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:28

Manufacturer products View details

RöKo-Filling-Line 2M

Kontrastmittel-Applikations-Set 12h

Class IIaMDR 2017/745On the marketSterile

Manufacturer: CARDEA GmbH & Co. KG
Manufacturer SRN: DE-MF-000006460
UDI-DI: 04260590630025
Basic UDI-DI: 426059063000002AA
Reference: rkp-FL-2M
EMDN: Z11050185
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:21

Manufacturer products View details

RöKo-Filling-Line 2

Kontrastmittel-Applikations-Set 12h

Class IIaMDR 2017/745On the marketSterile

Manufacturer: CARDEA GmbH & Co. KG
Manufacturer SRN: DE-MF-000006460
UDI-DI: 04260590630001
Basic UDI-DI: 426059063000002AA
Reference: rkp-FL-2
EMDN: Z11050185
EMDN description: MAGNETIC RESONANCE (MR) SYSTEMS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:12

Manufacturer products View details