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    <udiDi>15099590744359</udiDi>
    <basicUdiDi>150995901LumiphosVQ</basicUdiDi>
    <tradeName>Lumi-Phos PRO</tradeName>
    <deviceName>Lumi-Phos PRO</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B96000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:35.830Z</lastUpdated>
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  <row>
    <udiDi>06950996004503</udiDi>
    <basicUdiDi>B-06950996004503</basicUdiDi>
    <tradeName>Quantitative Analysis Kit for Four Inflammatory Markers (Flowcytometry Fluorescence Method)</tradeName>
    <deviceName>Quantitative Analysis Kit for Four Inflammatory Markers (Flowcytometry Fluorescence Method)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1IF4B11</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:33:03.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996004466</udiDi>
    <basicUdiDi>B-06950996004466</basicUdiDi>
    <tradeName>Quantitative Analysis Kit for Alpha-fetoprotein and Carcino-embryonic antigen (Flowcytometry Fluorescence Method)</tradeName>
    <deviceName>Quantitative Analysis Kit for Alpha-fetoprotein and Carcino-embryonic antigen (Flowcytometry Fluorescence Method)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1TM2B11</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:32:54.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996004459</udiDi>
    <basicUdiDi>B-06950996004459</basicUdiDi>
    <tradeName>Quantitative Analysis Kit for Pepsinogen I, Pepsinogen II and Gastrin-17(Flowcytometry Fluorescence Method)</tradeName>
    <deviceName>Quantitative Analysis Kit for Pepsinogen I, Pepsinogen II and Gastrin-17(Flowcytometry Fluorescence Method)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1GF3B11</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:32:53.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996004442</udiDi>
    <basicUdiDi>B-06950996004442</basicUdiDi>
    <tradeName>Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method)</tradeName>
    <deviceName>Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1AA15B11</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:32:46.995Z</lastUpdated>
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  <row>
    <udiDi>06950996004435</udiDi>
    <basicUdiDi>B-06950996004435</basicUdiDi>
    <tradeName>Quantitative Analysis Kit for Six Tumor Markers (Flowcytometry Fluorescence Method)</tradeName>
    <deviceName>Quantitative Analysis Kit for Six Tumor Markers (Flowcytometry Fluorescence Method)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1TM6B11</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:32:46.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996004428</udiDi>
    <basicUdiDi>B-06950996004428</basicUdiDi>
    <tradeName>Quantitative Analysis Kit for Seven Tumor Markers (Flowcytometry Fluorescence Method)</tradeName>
    <deviceName>Quantitative Analysis Kit for Seven Tumor Markers (Flowcytometry Fluorescence Method)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1TM7B11</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:32:44.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996004411</udiDi>
    <basicUdiDi>B-06950996004411</basicUdiDi>
    <tradeName>Quantitative Analysis Kit for Three Tumor Markers (Flowcytometry Fluorescence Method)</tradeName>
    <deviceName>Quantitative Analysis Kit for Three Tumor Markers (Flowcytometry Fluorescence Method)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1TM3B11</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:32:43.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293580279</udiDi>
    <basicUdiDi>697518250P120055T</basicUdiDi>
    <tradeName>Troponin I/Creatine Kinase Isoenzymes MB/Myoglobin Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Troponin I/Creatine Kinase Isoenzymes MB/Myoglobin Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P12005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:22:21.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415918699</udiDi>
    <basicUdiDi>69449040004JD-Dimer****Q7</basicUdiDi>
    <tradeName>D-Dimer kit (Particle-enhanced Immunoturbidimetric Assay Method)</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-012738-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:25:30.726Z</lastUpdated>
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