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    <tradeName>BF-FDTI Lyse</tradeName>
    <deviceName>BF-FDTI Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019973</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:53.431Z</lastUpdated>
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    <udiDi>06925794577849</udiDi>
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    <tradeName>BF-WFL Lyse</tradeName>
    <deviceName>BF-WFL Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <reference>3019978</reference>
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    <lastUpdated>2026-07-31T16:26:47.031Z</lastUpdated>
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    <tradeName>BF-FDT Lyse</tradeName>
    <deviceName>BF-FDT Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:46.226Z</lastUpdated>
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    <udiDi>06925794577764</udiDi>
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    <tradeName>BF-WNL Lyse</tradeName>
    <deviceName>BF-WNL Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019960</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:45.434Z</lastUpdated>
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    <udiDi>06925794577757</udiDi>
    <basicUdiDi>69422022W010301010509R08H</basicUdiDi>
    <tradeName>BF-CRP Lyse</tradeName>
    <deviceName>BF-CRP Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019904</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:41.429Z</lastUpdated>
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    <udiDi>06925794577726</udiDi>
    <basicUdiDi>69422022W010301010507R087</basicUdiDi>
    <tradeName>BCC-3D Lyse</tradeName>
    <deviceName>BCC-3D Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019949</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:40.633Z</lastUpdated>
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    <udiDi>06925794577603</udiDi>
    <basicUdiDi>69422022W010301010501R079</basicUdiDi>
    <tradeName>Lyse</tradeName>
    <deviceName>Lyse</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019937</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:26:40.138Z</lastUpdated>
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    <udiDi>06936895302766</udiDi>
    <basicUdiDi>69368953HAL132R5</basicUdiDi>
    <tradeName>Hematology Analyzer Lyse</tradeName>
    <deviceName>Hematology Analyzer Lyse</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFL 500mL（10103）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:00:44.728Z</lastUpdated>
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    <basicUdiDi>69368953HAD133PF</basicUdiDi>
    <tradeName>Hematology Analyzer Diluent</tradeName>
    <deviceName>Hematology Analyzer Diluent</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10×SFL-1 2L（10106）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:00:43.079Z</lastUpdated>
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    <udiDi>06934175046249</udiDi>
    <basicUdiDi>6934175002B0030NY</basicUdiDi>
    <tradeName>Hematology Reagent Kit</tradeName>
    <deviceName>Hematology Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12600777</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:56:11.739Z</lastUpdated>
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    <udiDi>06934175010288</udiDi>
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    <tradeName>06934175010288</tradeName>
    <deviceName>Portable Automatic Multi-function Analyzer</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3V001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:56:04.533Z</lastUpdated>
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    <udiDi>06925794577641</udiDi>
    <basicUdiDi>69257945W0103010199R0PF</basicUdiDi>
    <tradeName>BF-WFF Dye</tradeName>
    <deviceName>Hematology Reagent</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019941</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:28:12.783Z</lastUpdated>
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    <basicUdiDi>69257945W0103010105R0LU</basicUdiDi>
    <tradeName>Probe Cleanser(BCC-3000)</tradeName>
    <deviceName>Hematology Reagent</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3002433</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:27:26.295Z</lastUpdated>
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    <basicUdiDi>5999883586HYPY9</basicUdiDi>
    <tradeName>Diatro•Hypoclean</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000020416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D7011</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:47:13.237Z</lastUpdated>
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    <basicUdiDi>5999862176BioStainRETAK</basicUdiDi>
    <tradeName>BioStain RET fluorescent reticulocyte 12mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S021</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:42.088Z</lastUpdated>
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    <basicUdiDi>5999862366BioStainNRBCZT</basicUdiDi>
    <tradeName>BioStain NRBC fluorescent NRBC 12mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S024</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:23.033Z</lastUpdated>
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    <basicUdiDi>5999862366BioStainW5PB4</basicUdiDi>
    <tradeName>BioStain W5P fluorescent WBC-5-diff dye 42mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>S028</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:22.207Z</lastUpdated>
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    <tradeName>BioLyse W5P WBC-5-diff lysing reagent 5L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L027</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:21.403Z</lastUpdated>
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    <basicUdiDi>5999862366BioLyseNRBC96</basicUdiDi>
    <tradeName>BioLyse NRBC NRBC specific lysing  reagent 1L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L021</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:20.607Z</lastUpdated>
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    <basicUdiDi>5999862366BioDilRETZA</basicUdiDi>
    <tradeName>BioDil RET reticulocyte buffer 1L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BioDil RET reticulocyte buffer 1L</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:16.604Z</lastUpdated>
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