<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06952804817459</udiDi>
    <basicUdiDi>B-06952804817459</basicUdiDi>
    <tradeName>Transferrin and Fecal Occult Blood and Haptoglobin­hemoglobin Combo Test Device</tradeName>
    <deviceName>Transferrin and Fecal Occult Blood and Haptoglobin­hemoglobin Combo Test Device</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>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MT-F43M002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:31:18.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803445</udiDi>
    <basicUdiDi>B-06952804803445</basicUdiDi>
    <tradeName>β2MG FIA</tradeName>
    <deviceName>β2MG FIA</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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>β2mg-W23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:24:51.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802844</udiDi>
    <basicUdiDi>B-06952804802844</basicUdiDi>
    <tradeName>AFP FIA</tradeName>
    <deviceName>AFP FIA</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>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFP-W23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:23:15.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802462</udiDi>
    <basicUdiDi>B-06952804802462</basicUdiDi>
    <tradeName>β2-microglobulin Chemiluminescence Immunoassay Test Kit</tradeName>
    <deviceName>β2-microglobulin Chemiluminescence Immunoassay Test Kit</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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G217A08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:22:54.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802363</udiDi>
    <basicUdiDi>B-06952804802363</basicUdiDi>
    <tradeName>Alpha Fetoprotein Chemiluminescence Immunoassay Test Kit</tradeName>
    <deviceName>Alpha Fetoprotein Chemiluminescence Immunoassay Test Kit</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>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G200A08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:22:28.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951045811530</udiDi>
    <basicUdiDi>69510458SF_AFPVQ</basicUdiDi>
    <tradeName>06951045811530</tradeName>
    <deviceName>SuperFlex AFP Kit</deviceName>
    <manufacturerName>Suzhou Sym-Bio Lifescience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012847</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY490QG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:36:44.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950334813798</udiDi>
    <basicUdiDi>B-06950334813798</basicUdiDi>
    <tradeName>Alpha Fetoprotein (AFP) Test Kit (Immunofluorescence)</tradeName>
    <deviceName>Alpha Fetoprotein (AFP) Test Kit (Immunofluorescence)</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52026122</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:41:35.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145583514</udiDi>
    <basicUdiDi>69471455612WC</basicUdiDi>
    <tradeName>Biossays β2-Microglobulin (Latex Immunoturbidimetric)</tradeName>
    <deviceName>β2-Microglobulin (Latex Immunoturbidimetric)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130553007A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:03.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145583460</udiDi>
    <basicUdiDi>69471455612WC</basicUdiDi>
    <tradeName>Biossays β2-Microglobulin (Latex Immunoturbidimetric)</tradeName>
    <deviceName>β2-Microglobulin (Latex Immunoturbidimetric)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130553007S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:02.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145501303</udiDi>
    <basicUdiDi>B-06947145501303</basicUdiDi>
    <tradeName>MAGLUMI S-100 (CLIA)</tradeName>
    <deviceName>S-100 (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039012</emdnCode>
    <emdnDescription>PROTEIN S-100 B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130201017M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:25.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145500948</udiDi>
    <basicUdiDi>B-06947145500948</basicUdiDi>
    <tradeName>MAGLUMI β2-MG (CLIA)</tradeName>
    <deviceName>β2-MG (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130204001M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:21.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590827</udiDi>
    <basicUdiDi>697518250F12212ZV</basicUdiDi>
    <tradeName>Neuron Specific Enolase CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Neuron Specific Enolase 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>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F12212</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:30:33.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590728</udiDi>
    <basicUdiDi>697518250F1300622</basicUdiDi>
    <tradeName>Gastrin Releasing Peptide Precursor CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Gastrin Releasing Peptide Precursor 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>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F13006</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:30:11.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293590209</udiDi>
    <basicUdiDi>697518250F12203ZU</basicUdiDi>
    <tradeName>Alpha-fetoprotein CLIA Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Alpha-fetoprotein 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>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F12203</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:28:07.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293580941</udiDi>
    <basicUdiDi>697518250P115076H</basicUdiDi>
    <tradeName>Fecal Occult Blood Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Fecal Occult Blood 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11507</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:24:32.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293580804</udiDi>
    <basicUdiDi>697518250P115056D</basicUdiDi>
    <tradeName>FOB-TRF Combo Rapid Test Kit</tradeName>
    <deviceName>FOB-TRF Combo Rapid Test Kit</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>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11505</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:24:12.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293580118</udiDi>
    <basicUdiDi>697518250P1220463</basicUdiDi>
    <tradeName>Alpha-fetoprotein Determination Kit (Fluorescence Immunochromatographic Assay)	W0102039001</tradeName>
    <deviceName>Alpha-fetoprotein 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>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P12204</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:22:02.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942028503092</udiDi>
    <basicUdiDi>B-06942028503092</basicUdiDi>
    <tradeName>S100 Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>S100 Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:17:03.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942028502606</udiDi>
    <basicUdiDi>B-06942028502606</basicUdiDi>
    <tradeName>Protein Induced by Vitamin K Absence or Antagonist-Ⅱ (PIVKAⅡ) Assay Kit(Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Protein Induced by Vitamin K Absence or Antagonist-Ⅱ (PIVKAⅡ) Assay Kit(Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039017</emdnCode>
    <emdnDescription>PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD2101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:16:59.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941967231127</udiDi>
    <basicUdiDi>B-06941967231127</basicUdiDi>
    <tradeName>06941967231127</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0602001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-25T17:49:21.091Z</lastUpdated>
  </row>
</eudamedExport>