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DIARM DM MULTI

Radiology Software

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: MEDICAL TECHNOLOGIES Ltd
Manufacturer SRN: RU-MF-000020612
UDI-DI: 04630193910204
Basic UDI-DI: 463019391RadiologySWAT
Reference: F0328E
EMDN: Z11031182
EMDN description: SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 31.07.2026 06:20

Manufacturer products Authorised representative products Authorised representative actors View details

SOLO DMR

SOLO

Class IIaMDR 2017/745Not intended for EU marketActive deviceDirect marking

Manufacturer: MEDICAL TECHNOLOGIES Ltd
Manufacturer SRN: RU-MF-000020612
UDI-DI: 04630193910013
Basic UDI-DI: 463019391SOLODetectorsS3
Reference: F0409E
EMDN: Z11031180
EMDN description: SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 31.07.2026 06:20

Manufacturer products Authorised representative products Authorised representative actors View details

MS X-RAY GRID

Class IMDR 2017/745On the market

Manufacturer: Mitaya Manufacturing Co., Ltd.
Manufacturer SRN: JP-MF-000053032
UDI-DI: 04589744208294
Basic UDI-DI: 458974417MitayaGridFZ
Reference: 5807211-2 A7202DF
EMDN: Z11039080
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 31.07.2026 06:18

Manufacturer products Authorised representative products Authorised representative actors View details

X-Ray FLAT PANEL IMAGER FDX3334RF

X-ray Flat Panel Imager

Class IMDR 2017/745On the marketActive device

Manufacturer: CANON ELECTRON TUBES & DEVICES CO., LTD.
Manufacturer SRN: JP-MF-000009481
UDI-DI: 04580274419013
Basic UDI-DI: 45802744125364940471340LB
Reference: -
EMDN: Z11039099
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER
First on market country: Netherlands
Authorised representative: Canon Medical Components Europe B.V.
Last updated: 31.07.2026 06:14

Manufacturer products Authorised representative products Authorised representative actors View details

X-ray Image Intensifier E5759HD-P1

X-ray Image Intensifier

Class IMDR 2017/745On the marketActive device

Manufacturer: CANON ELECTRON TUBES & DEVICES CO., LTD.
Manufacturer SRN: JP-MF-000009481
UDI-DI: 04580274414155
Basic UDI-DI: 45802744118495440495344RZ
Reference: -
EMDN: Z11039015
EMDN description: IMAGE INTENSIFIERS
First on market country: Germany
Authorised representative: Canon Medical Components Europe B.V.
Last updated: 31.07.2026 06:14

Manufacturer products Authorised representative products Authorised representative actors View details

ROTANODE DRX-1603B

X-ray Tube Assembly

Class IIbMDR 2017/745On the marketActive device

Manufacturer: CANON ELECTRON TUBES & DEVICES CO., LTD.
Manufacturer SRN: JP-MF-000009481
UDI-DI: 04580274410119
Basic UDI-DI: 45802744133523659295537M9
Reference: -
EMDN: Z11039012
EMDN description: X-RAY TUBE ASSEMBLY
First on market country: Netherlands
Authorised representative: Canon Medical Components Europe B.V.
Last updated: 31.07.2026 06:14

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

FLAT PANEL DETECTOR AR-B2735W

FLAT PANEL DETECTOR

Class IMDR 2017/745On the marketActive device

Manufacturer: Canon Inc.
Manufacturer SRN: JP-MF-000013254
UDI-DI: 04549292167658
Basic UDI-DI: 4549292fp01CY
Reference: BT8-1692
EMDN: Z11031101
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
First on market country: Netherlands
Authorised representative: Canon Medical Components Europe B.V.
Last updated: 31.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

DIGITAL RADIOGRAPHY CXDI-710C Wireless

Digital Radiography

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Canon Inc.
Manufacturer SRN: JP-MF-000013254
UDI-DI: 04549292099447
Basic UDI-DI: 4549292dr01CU
Reference: BT8- 1846
EMDN: Z11031101
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
First on market country: Netherlands
Authorised representative: Canon Medical Components Europe B.V.
Last updated: 31.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

i-Dixel

Class IMDR 2017/745On the market

Manufacturer: J. MORITA MFG. CORP.
Manufacturer SRN: JP-MF-000023000
UDI-DI: 04548213030804
Basic UDI-DI: 4548213000B0022DV
Reference: i-Dixel
EMDN: Z11030682
EMDN description: COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

Veraview X800

X800

Class IIbMDR 2017/745On the marketActive device

Manufacturer: J. MORITA MFG. CORP.
Manufacturer SRN: JP-MF-000023000
UDI-DI: 04548213030798
Basic UDI-DI: 4548213000B0017E4
Reference: X800
EMDN: Z1103030102
EMDN description: EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

XD2000 ST-S

Class IMDR 2017/745On the market

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410438895
Basic UDI-DI: 454741010100000000001253M
Reference: 04547410438895
EMDN: Z11039080
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

XD2000 RS

Class IMDR 2017/745On the marketActive device

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410438864
Basic UDI-DI: 454741010100000000001233H
Reference: 04547410438864
EMDN: Z11039080
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

898Y101490

Lateral Option

Class IMDR 2017/745On the market

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410242331
Basic UDI-DI: 454741010100000000000913V
Reference: 04547410242331
EMDN: Z1103028001
EMDN description: STEREOTACTIC MODULES FOR MAMMOGRAPHY
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

356Y120173

Biopsy Accessory

Class IMDR 2017/745On the marketDirect marking

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410347517
Basic UDI-DI: 454741010100000000000903T
Reference: 04547410347517
EMDN: Z1103028001
EMDN description: STEREOTACTIC MODULES FOR MAMMOGRAPHY
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 05:54

Manufacturer products Authorised representative products Authorised representative actors View details

401Y120038

Shift Compression Plate

Class IMDR 2017/745On the market

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410302769
Basic UDI-DI: 4547410101000000000008746
Reference: 04547410302769
EMDN: Z1103028099
EMDN description: MAMMOGRAPHY SYSTEMS - HARDWARE - OTHER
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

898Y101468

Face Guard

Class IMDR 2017/745On the market

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410249965
Basic UDI-DI: 4547410101000000000008542
Reference: 04547410249965
EMDN: Z1103028099
EMDN description: MAMMOGRAPHY SYSTEMS - HARDWARE - OTHER
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

FDR-2000BPY

Biopsy Positioner

Class IMDR 2017/745On the marketActive device

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410242294
Basic UDI-DI: 454741010100000000000894A
Reference: 04547410242294
EMDN: Z1103028001
EMDN description: STEREOTACTIC MODULES FOR MAMMOGRAPHY
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

401Y100118

Compression Plate

Class IMDR 2017/745On the market

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410241990
Basic UDI-DI: 454741010100000000000653U
Reference: 04547410241990
EMDN: Z1103028099
EMDN description: MAMMOGRAPHY SYSTEMS - HARDWARE - OTHER
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details