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    <tradeName>CN-3500</tradeName>
    <deviceName>Automated Blood Coagulation Analyzer</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AX818921</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:36:13.371Z</lastUpdated>
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    <udiDi>04987562502967</udiDi>
    <basicUdiDi>4987562CN-6500N2</basicUdiDi>
    <tradeName>CN-6500</tradeName>
    <deviceName>Automated Blood Coagulation Analyzer CN-6500</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BH584790</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:36:12.586Z</lastUpdated>
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    <udiDi>04987562501908</udiDi>
    <basicUdiDi>4987562PS-104R</basicUdiDi>
    <tradeName>PS-10</tradeName>
    <deviceName>Sample Preparation System PS-10</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BQ716341</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:36:10.979Z</lastUpdated>
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    <udiDi>04987562499700</udiDi>
    <basicUdiDi>4987562CN-3000LL</basicUdiDi>
    <tradeName>CN-3000</tradeName>
    <deviceName>Automated Blood Coagulation Analyzer</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL971029</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:36:06.172Z</lastUpdated>
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    <udiDi>04987562499687</udiDi>
    <basicUdiDi>4987562CN-6000M9</basicUdiDi>
    <tradeName>CN-6000</tradeName>
    <deviceName>Automated Blood Coagulation Analyzer CN-6000</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CV339763</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:36:04.568Z</lastUpdated>
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    <udiDi>04987562470617</udiDi>
    <basicUdiDi>4987562RR-205B</basicUdiDi>
    <tradeName>RR-20</tradeName>
    <deviceName>Reservoir tank RR-20</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029080</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT932479</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:35:51.768Z</lastUpdated>
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    <udiDi>04987562468041</udiDi>
    <basicUdiDi>4987562SP-505H</basicUdiDi>
    <tradeName>SP-50</tradeName>
    <deviceName>Automated Hematology Slide Preparation Unit</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX765805</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:35:47.758Z</lastUpdated>
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    <udiDi>04987562433742</udiDi>
    <basicUdiDi>4987562CS-2400P2</basicUdiDi>
    <tradeName>CS-2400</tradeName>
    <deviceName>AUTOMATED BLOOD COAGULATION ANALYZER</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AR780981</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:35:41.359Z</lastUpdated>
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    <udiDi>04987562433735</udiDi>
    <basicUdiDi>4987562CS-2500P7</basicUdiDi>
    <tradeName>CS-2500</tradeName>
    <deviceName>AUTOMATED BLOOD COAGULATION ANALYZER</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BV981798</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:35:40.549Z</lastUpdated>
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    <udiDi>04987562433254</udiDi>
    <basicUdiDi>4987562CS-1600P5</basicUdiDi>
    <tradeName>CS-1600</tradeName>
    <deviceName>AUTOMATED BLOOD COAGULATION ANALYZER</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BQ203979</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:35:38.946Z</lastUpdated>
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    <udiDi>04987562430918</udiDi>
    <basicUdiDi>4987562ConnectionUnitVK</basicUdiDi>
    <tradeName>CF-60</tradeName>
    <deviceName>Connection Unit for DI-60</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029080</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BN868986</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:35:34.145Z</lastUpdated>
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    <udiDi>04987562428335</udiDi>
    <basicUdiDi>4987562ReservoirTank9C</basicUdiDi>
    <tradeName>RR-10</tradeName>
    <deviceName>Reservoir Tank RR-10</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029080</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC479026</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:35:16.488Z</lastUpdated>
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    <udiDi>04987562425662</udiDi>
    <basicUdiDi>4987562CA-600N2</basicUdiDi>
    <tradeName>CA-650</tradeName>
    <deviceName>Automated Blood Coagulation Analyzer CA-600 series</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AR822623</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:35:15.698Z</lastUpdated>
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    <udiDi>04987562425426</udiDi>
    <basicUdiDi>4987562CS-5100P8</basicUdiDi>
    <tradeName>CS-5100</tradeName>
    <deviceName>Automated Blood Coagulation Analyzer</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BY990757</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:35:11.689Z</lastUpdated>
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    <udiDi>04987562424481</udiDi>
    <basicUdiDi>4987562RU-205Y</basicUdiDi>
    <tradeName>RU-20</tradeName>
    <deviceName>Reagent Unit</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CY662767</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:35:10.888Z</lastUpdated>
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    <udiDi>04946433600652</udiDi>
    <basicUdiDi>49464337722UZ</basicUdiDi>
    <tradeName>Tissue-Tek Xpress</tradeName>
    <deviceName>Tissue-Tek Xpress x120</deviceName>
    <manufacturerName>Sakura Seiki Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000022209</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059010</emdnCode>
    <emdnDescription>TISSUE PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7722</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:26:51.913Z</lastUpdated>
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    <udiDi>04946433600638</udiDi>
    <basicUdiDi>49464334742UJ</basicUdiDi>
    <tradeName>Tissue-Tek Film</tradeName>
    <deviceName>Tissue-Tek Film</deviceName>
    <manufacturerName>Sakura Seiki Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000022209</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-31T04:26:47.920Z</lastUpdated>
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    <deviceName>Tissue-Tek Prisma Plus</deviceName>
    <manufacturerName>Sakura Seiki Co., Ltd.</manufacturerName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUTOMATED SLIDE STAINERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <manufacturerName>Sakura Seiki Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000022209</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>AUTOMATED SLIDE STAINERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6172</reference>
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    <lastUpdated>2026-07-31T04:26:46.308Z</lastUpdated>
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    <deviceName>Tissue-Tek Glas g2</deviceName>
    <manufacturerName>Sakura Seiki Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000022209</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6502</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:26:45.515Z</lastUpdated>
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