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    <tradeName>Hematology Control</tradeName>
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    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XQ-0007-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:25:07.068Z</lastUpdated>
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    <udiDi>06945429026603</udiDi>
    <basicUdiDi>B-06945429026603</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:58.981Z</lastUpdated>
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    <basicUdiDi>B-06945429026597</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:57.784Z</lastUpdated>
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    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:56.632Z</lastUpdated>
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    <udiDi>06945429026542</udiDi>
    <basicUdiDi>B-06945429026542</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:47.520Z</lastUpdated>
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    <udiDi>06945429026535</udiDi>
    <basicUdiDi>B-06945429026535</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:39.862Z</lastUpdated>
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    <udiDi>06945429026528</udiDi>
    <basicUdiDi>B-06945429026528</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:38.580Z</lastUpdated>
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    <tradeName>ADVIA 120/2120/2120i® AUTOretic</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10312271</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:35:39.679Z</lastUpdated>
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    <udiDi>08592156113199</udiDi>
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    <tradeName>ELite H5 CON N</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T04:23:25.945Z</lastUpdated>
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    <basicUdiDi>8592156HECON3032Y</basicUdiDi>
    <tradeName>ELite H5 CON H</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00026</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T04:23:25.928Z</lastUpdated>
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    <basicUdiDi>8592156HECON30432</basicUdiDi>
    <tradeName>Erba H3 CON N</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00034</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T04:23:25.714Z</lastUpdated>
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    <basicUdiDi>8592156HECON30432</basicUdiDi>
    <tradeName>Erba H3 CON H</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00035</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T04:23:25.696Z</lastUpdated>
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    <udiDi>08592156325295</udiDi>
    <basicUdiDi>8592156H7CON301TU</basicUdiDi>
    <tradeName>Erba H7 CON N</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00057</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T04:23:25.525Z</lastUpdated>
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    <tradeName>Erba H7 CON H</tradeName>
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    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T04:23:25.500Z</lastUpdated>
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    <tradeName>Erba H7 ret CON N</tradeName>
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    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-21T04:23:25.451Z</lastUpdated>
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    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
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    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
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    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
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    <tradeName>Erba H7 ret CON</tradeName>
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    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
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    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00059</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T04:23:24.995Z</lastUpdated>
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