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<eudamedExport entity="devices">
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    <udiDi>06974969981356</udiDi>
    <basicUdiDi>B-06974969981356</basicUdiDi>
    <tradeName>Neuron-specific Enolase（NSE）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Neuron-specific Enolase（NSE）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/kit（DR1095-1）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:10:35.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974671100519</udiDi>
    <basicUdiDi>B-06974671100519</basicUdiDi>
    <tradeName>06974671100519</tradeName>
    <deviceName>Neuron-specific Enolase Quantitative Diagnostic Kit (CLIA)</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CLIA-CM-B005</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:07:32.708Z</lastUpdated>
  </row>
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    <udiDi>06974671100502</udiDi>
    <basicUdiDi>B-06974671100502</basicUdiDi>
    <tradeName>06974671100502</tradeName>
    <deviceName>Neuron-specific Enolase Quantitative Diagnostic Kit (CLIA)</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CLIA-CM-A005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:07:28.808Z</lastUpdated>
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    <udiDi>06974671100069</udiDi>
    <basicUdiDi>B-06974671100069</basicUdiDi>
    <tradeName>06974671100069</tradeName>
    <deviceName>Neuron-Specific Enolase (NSE) Diagnostic Kit (TRFIA)</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CM-A016</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:06:53.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719604371</udiDi>
    <basicUdiDi>B-06972719604371</basicUdiDi>
    <tradeName>06972719604371</tradeName>
    <deviceName>Neuron Specific Enolase Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:46:25.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719604364</udiDi>
    <basicUdiDi>B-06972719604364</basicUdiDi>
    <tradeName>06972719604364</tradeName>
    <deviceName>Neuron Specific Enolase Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:46:21.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719602827</udiDi>
    <basicUdiDi>B-06972719602827</basicUdiDi>
    <tradeName>06972719602827</tradeName>
    <deviceName>Neuron Specific Enolase Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:41:02.221Z</lastUpdated>
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  <row>
    <udiDi>06972719602810</udiDi>
    <basicUdiDi>B-06972719602810</basicUdiDi>
    <tradeName>06972719602810</tradeName>
    <deviceName>Neuron Specific Enolase Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:41:00.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719602803</udiDi>
    <basicUdiDi>B-06972719602803</basicUdiDi>
    <tradeName>06972719602803</tradeName>
    <deviceName>Neuron Specific Enolase Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:40:58.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719600700</udiDi>
    <basicUdiDi>B-06972719600700</basicUdiDi>
    <tradeName>06972719600700</tradeName>
    <deviceName>Neuron Specific Enolase Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>215790004</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:32:59.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971792050976</udiDi>
    <basicUdiDi>B-06971792050976</basicUdiDi>
    <tradeName>Neuron-Specific Enolase (NSE) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KA008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:53:03.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904091150</udiDi>
    <basicUdiDi>69449040004L-NSE*******DR</basicUdiDi>
    <tradeName>Neuron-specific enolase(CLIA)</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>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-005686-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:03.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904091181</udiDi>
    <basicUdiDi>69449040004L-NSE*******DR</basicUdiDi>
    <tradeName>NSE Calibrators</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>W0102039007</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-005920-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:03.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904091204</udiDi>
    <basicUdiDi>69449040004L-NSE*******DR</basicUdiDi>
    <tradeName>NSE Control</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>W0102039007</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-005937-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:03.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904091211</udiDi>
    <basicUdiDi>69449040004L-NSE*******DR</basicUdiDi>
    <tradeName>NSE Control</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>W0102039007</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-005938-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:03.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904091228</udiDi>
    <basicUdiDi>69449040004L-NSE*******DR</basicUdiDi>
    <tradeName>NSE Control</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>W0102039007</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-005951-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:03.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944904091235</udiDi>
    <basicUdiDi>69449040004L-NSE*******DR</basicUdiDi>
    <tradeName>NSE Control</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>W0102039007</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-005952-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:03.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770024321173</udiDi>
    <basicUdiDi>B-03770024321173</basicUdiDi>
    <tradeName>03770024321173</tradeName>
    <deviceName>ELSA-NSE</deviceName>
    <manufacturerName>Cisbio Bioassays</manufacturerName>
    <manufacturerSrn>FR-MF-000024051</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELSA-NSE</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:31:37.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939716404595</udiDi>
    <basicUdiDi>69713904301127E</basicUdiDi>
    <tradeName>HOKAPI™ NSE</tradeName>
    <deviceName>HOKAPI™ NSE</deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010112001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:39.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984062570</udiDi>
    <basicUdiDi>69703416803205025JB</basicUdiDi>
    <tradeName>Neuronen-Spezifische Enolase (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320501603</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:09:26.829Z</lastUpdated>
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