<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06952804817046</udiDi>
    <basicUdiDi>B-06952804817046</basicUdiDi>
    <tradeName>Alprazolam Rapid Test</tradeName>
    <deviceName>Alprazolam Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ALP-U11 ALP-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:20.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804816865</udiDi>
    <basicUdiDi>B-06952804816865</basicUdiDi>
    <tradeName>Zopiclone Rapid Test</tradeName>
    <deviceName>Zopiclone Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZOP-U11 ZOP-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:29:59.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293591800</udiDi>
    <basicUdiDi>697518250F114702H</basicUdiDi>
    <tradeName>Free Anti Pembrolizumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Free Anti Pembrolizumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11470</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:31:55.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590995</udiDi>
    <basicUdiDi>697518250F114362H</basicUdiDi>
    <tradeName>Pembrolizumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Pembrolizumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11436</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:31:17.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590988</udiDi>
    <basicUdiDi>697518250F114352F</basicUdiDi>
    <tradeName>Nivolumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Nivolumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11435</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:31:11.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590957</udiDi>
    <basicUdiDi>697518250F114382M</basicUdiDi>
    <tradeName>Free Anti-Bevacizumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Free Anti-Bevacizumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11438</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:31:08.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590940</udiDi>
    <basicUdiDi>697518250F114372K</basicUdiDi>
    <tradeName>Bevacizumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Bevacizumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11437</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:31:02.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590711</udiDi>
    <basicUdiDi>697518250F114452J</basicUdiDi>
    <tradeName>Rifampicin CLIA Kit（Chemiluminescence Immunoassay）</tradeName>
    <deviceName>Rifampicin CLIA Kit（Chemiluminescence Immunoassay）</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>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11445</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:30:10.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590704</udiDi>
    <basicUdiDi>697518250F114502B</basicUdiDi>
    <tradeName>Isoniazid CLIA Kit（Chemiluminescence Immunoassay）</tradeName>
    <deviceName>Isoniazid CLIA Kit（Chemiluminescence Immunoassay）</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>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11450</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:30:04.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590681</udiDi>
    <basicUdiDi>697518250F114192H</basicUdiDi>
    <tradeName>5-Fluorouracil CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>5-Fluorouracil CLIA Kit (Chemiluminescence Immunoassay)</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>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11419</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:30:01.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590674</udiDi>
    <basicUdiDi>697518250F114182F</basicUdiDi>
    <tradeName>Voriconazole CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Voriconazole CLIA Kit (Chemiluminescence Immunoassay)</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>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11418</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:30:00.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590650</udiDi>
    <basicUdiDi>697518250F114162B</basicUdiDi>
    <tradeName>Paclitaxel CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Paclitaxel CLIA Kit (Chemiluminescence Immunoassay)</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>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11416</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:29:53.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590643</udiDi>
    <basicUdiDi>697518250F1141529</basicUdiDi>
    <tradeName>Total Risperidone CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Total Risperidone CLIA Kit (Chemiluminescence Immunoassay)</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>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11415</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:29:52.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590612</udiDi>
    <basicUdiDi>697518250F1141223</basicUdiDi>
    <tradeName>Linezolid CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Linezolid CLIA Kit (Chemiluminescence Immunoassay)</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>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11412</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:29:44.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590360</udiDi>
    <basicUdiDi>697518250F114392P</basicUdiDi>
    <tradeName>Trastuzumab CLIA kit (Chemiluminescence Immunoassay)W01020899</tradeName>
    <deviceName>Trastuzumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11439</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:28:44.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293581139</udiDi>
    <basicUdiDi>697518250P114176F</basicUdiDi>
    <tradeName>Rifampicin Determination Kit（Fluorescence Immunochromatographic Assay）</tradeName>
    <deviceName>Rifampicin 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>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11417</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:24:54.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293581122</udiDi>
    <basicUdiDi>697518250P114186H</basicUdiDi>
    <tradeName>Isoniazid Determination Kit（Fluorescence Immunochromatographic Assay）</tradeName>
    <deviceName>Isoniazid 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>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11418</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:24:53.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293580866</udiDi>
    <basicUdiDi>697518250P114156B</basicUdiDi>
    <tradeName>5-Fluorouracil Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>5-Fluorouracil Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11415</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:24:23.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293580514</udiDi>
    <basicUdiDi>697518250P1142064</basicUdiDi>
    <tradeName>Paclitaxel Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Paclitaxel 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>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11420</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:22:44.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293552238</udiDi>
    <basicUdiDi>697518250P114596X</basicUdiDi>
    <tradeName>Free Anti-Trastuzumab CLIA kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Free Anti-Trastuzumab CLIA kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020899</emdnCode>
    <emdnDescription>THERAPEUTIC DRUG MONITORING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11459</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:21:42.980Z</lastUpdated>
  </row>
</eudamedExport>