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    <tradeName>FDR-2000BPY</tradeName>
    <deviceName>Biopsy Positioner</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STEREOTACTIC MODULES FOR MAMMOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410242294</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:52:31.335Z</lastUpdated>
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    <udiDi>04547410211337</udiDi>
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    <tradeName>347N100859</tradeName>
    <deviceName>Lateral Option</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103028099</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - HARDWARE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410211337</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:52:30.630Z</lastUpdated>
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    <udiDi>04547410177121</udiDi>
    <basicUdiDi>454741010100000000000333F</basicUdiDi>
    <tradeName>FUJI IMAGING PLATE HR-VI</tradeName>
    <deviceName>FUJI IMAGING PLATE HR-VI</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11060285</emdnCode>
    <emdnDescription>DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410177121</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:52:28.928Z</lastUpdated>
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    <udiDi>04547410143096</udiDi>
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    <tradeName>356Y101200</tradeName>
    <deviceName>Biopsy Accessory</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103028001</emdnCode>
    <emdnDescription>STEREOTACTIC MODULES FOR MAMMOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410143096</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:52:28.149Z</lastUpdated>
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    <udiDi>04547410242010</udiDi>
    <basicUdiDi>454741010100000000000653U</basicUdiDi>
    <tradeName>401Y100115</tradeName>
    <deviceName>Compression Plate</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - HARDWARE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410242010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:52:27.333Z</lastUpdated>
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    <udiDi>04547410566949</udiDi>
    <basicUdiDi>454741050100000000000069Y</basicUdiDi>
    <tradeName>L52H</tradeName>
    <deviceName>L52H</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410566949</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:48:50.208Z</lastUpdated>
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    <udiDi>04547410566963</udiDi>
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    <tradeName>L43KM</tradeName>
    <deviceName>L43KM</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ULTRASOUND PROBES – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410566963</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:48:47.826Z</lastUpdated>
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    <udiDi>04547410558968</udiDi>
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    <tradeName>FCR PRIMA II</tradeName>
    <deviceName>CR-IR 391</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SINGLE-INPUT COMPUTED RADIOGRAPHY (CR) SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410558968</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:48:46.228Z</lastUpdated>
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    <udiDi>04547410513943</udiDi>
    <basicUdiDi>454741010100000000001353Q</basicUdiDi>
    <tradeName>AMULET SOPHINITY</tradeName>
    <deviceName>FDR MS-4000</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410513943</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:48:45.429Z</lastUpdated>
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    <udiDi>04547410542462</udiDi>
    <basicUdiDi>454741010100000000000343H</basicUdiDi>
    <tradeName>FCR PRIMA T</tradeName>
    <deviceName>CR-IR 392</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SINGLE-INPUT COMPUTED RADIOGRAPHY (CR) SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410542462</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:48:44.618Z</lastUpdated>
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    <udiDi>04547410542424</udiDi>
    <basicUdiDi>454741010100000000000223A</basicUdiDi>
    <tradeName>FCR CAPSULA XL II</tradeName>
    <deviceName>CR-IR 359</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SINGLE-INPUT COMPUTED RADIOGRAPHY (CR) SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410542424</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:48:43.831Z</lastUpdated>
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    <udiDi>04547410438888</udiDi>
    <basicUdiDi>454741010100000000001243K</basicUdiDi>
    <tradeName>XD2000 ST-M</tradeName>
    <deviceName>XD2000 ST-M</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039080</emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410438888</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:48:43.011Z</lastUpdated>
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    <udiDi>04547410438895</udiDi>
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    <tradeName>XD2000 ST-S</tradeName>
    <deviceName>XD2000 ST-S</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410438895</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:48:41.425Z</lastUpdated>
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    <udiDi>04547410431957</udiDi>
    <basicUdiDi>454741010100000000000353K</basicUdiDi>
    <tradeName>DRYPIX Smart</tradeName>
    <deviceName>DRYPIX 6000</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110705</emdnCode>
    <emdnDescription>LASER IMAGERS FOR BIOIMAGING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410431957</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:48:40.612Z</lastUpdated>
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    <udiDi>04547410368567</udiDi>
    <basicUdiDi>454741010100000000000523K</basicUdiDi>
    <tradeName>DRYPIX EDGE</tradeName>
    <deviceName>DRYPIX 8000</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110705</emdnCode>
    <emdnDescription>LASER IMAGERS FOR BIOIMAGING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410368567</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:48:39.020Z</lastUpdated>
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    <udiDi>04547410438864</udiDi>
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    <tradeName>XD2000 RS</tradeName>
    <deviceName>XD2000 RS</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410438864</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:48:38.215Z</lastUpdated>
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    <udiDi>04547410414530</udiDi>
    <basicUdiDi>454741010100000000000533M</basicUdiDi>
    <tradeName>FDR SE Console</tradeName>
    <deviceName>DR-ID 330CL</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIAGNOSTIC IMAGING WORKSTATIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410414530</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:48:36.608Z</lastUpdated>
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    <udiDi>04547410343793</udiDi>
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    <tradeName>FUJI IP CASSETTE Type CH</tradeName>
    <deviceName>FUJI IP CASSETTE Type CH</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410343793</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:48:35.020Z</lastUpdated>
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    <tradeName>FUJI IP CASSETTE LC</tradeName>
    <deviceName>FUJI IP CASSETTE LC</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410343687</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:48:34.233Z</lastUpdated>
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    <tradeName>DR-ID 800CL</tradeName>
    <deviceName>DR-ID 800CL</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DIAGNOSTIC IMAGING WORKSTATIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410333527</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:48:33.403Z</lastUpdated>
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