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    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-31T18:20:08.808Z</lastUpdated>
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    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
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    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
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    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
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    <reference>XQ-0069-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:20:02.413Z</lastUpdated>
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    <tradeName>Hematology Calibrator</tradeName>
    <deviceName>Hematology Calibrator</deviceName>
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    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Hematology Control</tradeName>
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    <lastUpdated>2026-07-31T18:19:58.403Z</lastUpdated>
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    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
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    <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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    <legislation>IVDR 2017/746</legislation>
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    <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>06903053011297</udiDi>
    <basicUdiDi>69449040XQSJ-003F******7Y</basicUdiDi>
    <tradeName>S50 Calibrator</tradeName>
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    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-026332-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:56:38.276Z</lastUpdated>
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    <udiDi>06903053029070</udiDi>
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    <tradeName>SC-CAL RET Hematology Calibrator</tradeName>
    <deviceName>SC-CAL RET Hematology Calibrator、BR60 Hematology Contro</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-018565-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:48:24.369Z</lastUpdated>
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    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <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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    <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>
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    <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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    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
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    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
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    <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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    <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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    <tradeName>NormaCal3 calibrator for Norma hematology analyzers</tradeName>
    <deviceName>NormaCal3 calibrator for Norma hematology analyzers</deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NIC-CAL32</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:35:52.152Z</lastUpdated>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <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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    <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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    <deviceName>HAEMATOLOGY CONTROL - LEVEL 1,2,3</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <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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    <tradeName>SULFOLYSER</tradeName>
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    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>904-1141-4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:41:54.870Z</lastUpdated>
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