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H2100X

Class IIbNot specifiedOn the marketActive device

Manufacturer: Hangzhou Kailong Medical Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000030241
UDI-DI: 06971564631228
Basic UDI-DI: 697156463XRTATL
Reference: H2100X-V1
EMDN: Z11039012
EMDN description: X-RAY TUBE ASSEMBLY
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 07:00

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H1076X

Class IIbNot specifiedOn the marketActive device

Manufacturer: Hangzhou Kailong Medical Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000030241
UDI-DI: 06971564631136
Basic UDI-DI: 697156463XRTATL
Reference: H1076X-0.6/1.5-125-V4
EMDN: Z11039012
EMDN description: X-RAY TUBE ASSEMBLY
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 07:00

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H1080X

Class IIbNot specifiedOn the marketActive device

Manufacturer: Hangzhou Kailong Medical Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000030241
UDI-DI: 06971564631174
Basic UDI-DI: 697156463XRTATL
Reference: H1080X-0.6/1.2-150-V1
EMDN: Z11039012
EMDN description: X-RAY TUBE ASSEMBLY
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 07:00

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H1080Y

Class IIbNot specifiedOn the marketActive device

Manufacturer: Hangzhou Kailong Medical Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000030241
UDI-DI: 06971564631198
Basic UDI-DI: 697156463XRTATL
Reference: H1080Y-0.6 1.2-150H（V2）
EMDN: Z11039012
EMDN description: X-RAY TUBE ASSEMBLY
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 07:00

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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

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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

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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

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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

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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

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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

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DRYPIX Lite

DRYPIX 2000

Class IMDR 2017/745On the marketActive device

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410207699
Basic UDI-DI: 454741010100000000000073E
Reference: 04547410207699
EMDN: Z11039003
EMDN description: MULTIFORMAT CAMERAS
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

X-ray tube assembly 0.4/0.7JG326D-265

X-ray tube assembly J-series

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Shimadzu Corporation
Manufacturer SRN: JP-MF-000025145
UDI-DI: 04540217042098
Basic UDI-DI: 45402170200000000000002U5
Reference: 582-24838-02
EMDN: Z11039012
EMDN description: X-RAY TUBE ASSEMBLY
First on market country: Germany
Authorised representative: Shimadzu Europa GmbH
Last updated: 31.07.2026 05:51

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PHOENIX 3000

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: medi-x Thomas Kadlubowski e.K.
Manufacturer SRN: DE-MF-000014103
UDI-DI: 04262586520006
Basic UDI-DI: 426258652PHX3000HA
Reference: 140051
EMDN: Z11039017
EMDN description: MOBILE RADIOSCOPIC UNITS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:43

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04262427650015

Perometer

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Pero-System GmbH
Manufacturer SRN: DE-MF-000013314
UDI-DI: 04262427650015
Basic UDI-DI: 426242765PerometerRH
Reference: Perometer 350 MT
EMDN: Z11039010
EMDN description: PHOTO CAMERAS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:33

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MSOT Frontier

SYS-MSOTFrontier

Class IIaMDR 2017/745On the marketActive device

Manufacturer: iThera Medical GmbH
Manufacturer SRN: DE-MF-000010082
UDI-DI: 04262380070028
Basic UDI-DI: 4262380070204TX
Reference: SYS-MSOTFrontier
EMDN: Z11039099
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:23

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MSOT Acuity Echo

SYS-MSOTACUITYechoCE2

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: iThera Medical GmbH
Manufacturer SRN: DE-MF-000010082
UDI-DI: 04262380070004
Basic UDI-DI: 4262380070203TV
Reference: SYS-MSOTACUITYechoCE2
EMDN: Z11039099
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:23

Manufacturer products View details

CONAXX 2

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: PROTEC X-ray Systems GmbH
Manufacturer SRN: DE-MF-000048351
UDI-DI: 04260502645741
Basic UDI-DI: 426050264D002UZ
Reference: 4330-0-0000
EMDN: Z11039082
EMDN description: VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:03

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PROSLIDE 32 SR System

Class IIbMDR 2017/745On the market

Manufacturer: PROTEC X-ray Systems GmbH
Manufacturer SRN: DE-PR-000048508
UDI-DI: 04260502642870
Basic UDI-DI: 426050264X027ZV
Reference: 7016-9-0000_V001
EMDN: Z11039016
EMDN description: MOBILE RADIOGRAPHIC UNITS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 02:03

Manufacturer products View details

PROSLIDE 32 B System

Class IIbMDR 2017/745On the market

Manufacturer: PROTEC X-ray Systems GmbH
Manufacturer SRN: DE-PR-000048508
UDI-DI: 04260502642542
Basic UDI-DI: 426050264X020ZF
Reference: 7017-9-0000_V001
EMDN: Z11039016
EMDN description: MOBILE RADIOGRAPHIC UNITS
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 02:03

Manufacturer products View details

PEDS 600 System

Class IIbMDR 2017/745On the market

Manufacturer: PROTEC X-ray Systems GmbH
Manufacturer SRN: DE-PR-000048508
UDI-DI: 04260502642481
Basic UDI-DI: 426050264X021ZH
Reference: 7095-9-8011_V013
EMDN: Z11039005
EMDN description: RADIOGENIC COMPLEXES
First on market country: -
Authorised representative: -
Last updated: 31.07.2026 02:03

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