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    <tradeName>Body Fluid-U</tradeName>
    <deviceName>ABF5</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
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    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
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    <reference>0EU010BAS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:57:16.415Z</lastUpdated>
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    <tradeName>Body Fluid-I</tradeName>
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    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
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    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
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    <basicUdiDi>B-00815762020070</basicUdiDi>
    <tradeName>Body Fluid-I</tradeName>
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    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
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    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
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    <tradeName>Body Fluid Control</tradeName>
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    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
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    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:57:10.611Z</lastUpdated>
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    <basicUdiDi>B-00815762020056</basicUdiDi>
    <tradeName>Body Fluid Control</tradeName>
    <deviceName>BF</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:57:09.705Z</lastUpdated>
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    <udiDi>06903053022811</udiDi>
    <basicUdiDi>69449040XQSJ-003J******A4</basicUdiDi>
    <tradeName>BC-BF Hematology Control</tradeName>
    <deviceName>BC-5D Hematology Control、 SC-CAL PLUS HEMATOLOGY CALIBRATOR、BC-3D Hematology Control、BC-6D Hematology Control、BC-BF HEMATOLOGY CONTROL</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-028639-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:56:47.080Z</lastUpdated>
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    <udiDi>06903053022460</udiDi>
    <basicUdiDi>69449040AB70000063U</basicUdiDi>
    <tradeName>BC-3D Hematology Control</tradeName>
    <deviceName>SC-CAL PLUS Hematology Calibrator、BC-3D Hematology Control、BC-5D Hematology Control、BC-6D Hematology Control</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-028604-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:56:46.268Z</lastUpdated>
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    <udiDi>06903053022453</udiDi>
    <basicUdiDi>69449040AB70000063U</basicUdiDi>
    <tradeName>BC-3D Hematology Control</tradeName>
    <deviceName>SC-CAL PLUS Hematology Calibrator、BC-3D Hematology Control、BC-5D Hematology Control、BC-6D Hematology Control</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-028603-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:47:57.461Z</lastUpdated>
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    <udiDi>06944413815827</udiDi>
    <basicUdiDi>69444138HematoryCon60DAJ</basicUdiDi>
    <tradeName>Hematology control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ED-60D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:41:42.176Z</lastUpdated>
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    <udiDi>06944413815773</udiDi>
    <basicUdiDi>69444138HematoryCon30DA3</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ED-30D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:41:41.126Z</lastUpdated>
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    <udiDi>06903053022712</udiDi>
    <basicUdiDi>69449040003NBC-RET*****3V</basicUdiDi>
    <tradeName>BC-RET Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-028629-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:36:42.682Z</lastUpdated>
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    <udiDi>05999106200160</udiDi>
    <basicUdiDi>59991062NormaCont56F</basicUdiDi>
    <tradeName>NormaCont5+ KIT K1 control blood set for 5-part differential Norma hematology analyzers - 2 low, 2 normal and 2 high vials</tradeName>
    <deviceName>NormaCont5+ KIT K1 control blood set for 5-part differential Norma hematology analyzers</deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NIC-053K1</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:35:48.141Z</lastUpdated>
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    <udiDi>05999106200122</udiDi>
    <basicUdiDi>59991062NormaCont36B</basicUdiDi>
    <tradeName>NormaCont3+ KIT K1 control blood set for 3-part differential Norma hematology analyzers - 2 low, 2 normal and 2 high vials</tradeName>
    <deviceName>NormaCont3+ KIT K1 control blood set for 3-part differential Norma hematology analyzers</deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NIC-032K1</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:35:46.543Z</lastUpdated>
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    <udiDi>05055273210200</udiDi>
    <basicUdiDi>50552732BHAECON0595S</basicUdiDi>
    <tradeName>HAEMATOLOGY CONTROL - LEVEL 1,2,3 (HAEM CNTL - LEVEL 1,2,3)</tradeName>
    <deviceName>HAEMATOLOGY CONTROL - LEVEL 1,2,3</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HM5162</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:12:01.693Z</lastUpdated>
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    <basicUdiDi>4931921IVD0010NL</basicUdiDi>
    <tradeName>HEMATOLOGY CONTROL+CRP MK-3CN</tradeName>
    <deviceName>CONTROL BLOOD MULTILEVEL</deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
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    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3CN03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:22:48.372Z</lastUpdated>
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    <basicUdiDi>4931921IVD0012NQ</basicUdiDi>
    <tradeName>HEMATOLOGY CONTROL for reticulocyte MK-RE1</tradeName>
    <deviceName>CONTROL BLOOD MULTILEVEL</deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
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    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE104</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:22:41.968Z</lastUpdated>
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    <tradeName>ESRtrol</tradeName>
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    <manufacturerName>HORIBA ABX SAS</manufacturerName>
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    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300128293</reference>
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    <lastUpdated>2026-07-30T18:12:55.118Z</lastUpdated>
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    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
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    <reference>2062207</reference>
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    <lastUpdated>2026-07-30T18:12:42.304Z</lastUpdated>
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    <manufacturerName>HORIBA ABX SAS</manufacturerName>
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    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1212042208</reference>
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    <tradeName>COULTER</tradeName>
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    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
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    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A59925</reference>
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    <lastUpdated>2026-07-30T17:32:35.564Z</lastUpdated>
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