<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-7C21DJ</udiDi>
    <basicUdiDi>B-7C21DJ</basicUdiDi>
    <tradeName>Squamous Cell Carcinoma assay (CLIA)</tradeName>
    <deviceName>Squamous Cell Carcinoma assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030116</emdnCode>
    <emdnDescription>SQUAMOUS CELL CARCINOMA ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7C21V1-B-EU, 7C21U1-B-EU, 7C21P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:59.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7C20DG</udiDi>
    <basicUdiDi>B-7C20DG</basicUdiDi>
    <tradeName>Carbohydrate Antigen 242 assay (CLIA)</tradeName>
    <deviceName>Carbohydrate Antigen 242 assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030108</emdnCode>
    <emdnDescription>CANCER ANTIGEN 242</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7C20V1-B-EU, 7C20U1-B-EU, 7C20P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:58.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7C15DP</udiDi>
    <basicUdiDi>B-7C15DP</basicUdiDi>
    <tradeName>Carbohydrate Antigen 72-4 assay (CLIA)</tradeName>
    <deviceName>Carbohydrate Antigen 72-4 assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7C15V1-B-EU, 7C15U1-B-EU, 7C15P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:40.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7C13DK</udiDi>
    <basicUdiDi>B-7C13DK</basicUdiDi>
    <tradeName>Cytokeratin 19 Fragment 21-1 assay (CLIA)</tradeName>
    <deviceName>Cytokeratin 19 Fragment 21-1 assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030111</emdnCode>
    <emdnDescription>CYFRA 21-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7C13V1-B-EU, 7C13U1-B-EU, 7C13P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:36.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7C10DD</udiDi>
    <basicUdiDi>B-7C10DD</basicUdiDi>
    <tradeName>Cancer Antigen 15-3 assay (CLIA)</tradeName>
    <deviceName>Cancer Antigen 15-3 assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7C10V1-B-EU, 7C10U1-B-EU, 7C10P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:35.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7C09DU</udiDi>
    <basicUdiDi>B-7C09DU</basicUdiDi>
    <tradeName>Neuron-Specific Enolase assay (CLIA)</tradeName>
    <deviceName>Neuron-Specific Enolase assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7C09V1-B-EU, 7C09U1-B-EU, 7C09P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:34.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7C04DJ</udiDi>
    <basicUdiDi>B-7C04DJ</basicUdiDi>
    <tradeName>Carbohydrate Antigen 19-9 assay (CLIA)</tradeName>
    <deviceName>Carbohydrate Antigen 19-9 assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7C04V1-B-EU, 7C04U1-B-EU, 7C04P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:30.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7C03DG</udiDi>
    <basicUdiDi>B-7C03DG</basicUdiDi>
    <tradeName>Cancer Antigen 125 assay (CLIA)</tradeName>
    <deviceName>Cancer Antigen 125 assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7C03V1-B-EU, 7C03U1-B-EU, 7C03P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:29.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7C02DE</udiDi>
    <basicUdiDi>B-7C02DE</basicUdiDi>
    <tradeName>Cancer Embryo Antigen assay (CLIA)</tradeName>
    <deviceName>Cancer Embryo Antigen assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7C02V1-B-EU, 7C02U1-B-EU, 7C02P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:28.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7C01DC</udiDi>
    <basicUdiDi>B-7C01DC</basicUdiDi>
    <tradeName>Alpha-Fetoprotein assay (CLIA)</tradeName>
    <deviceName>Alpha-Fetoprotein assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7C01V1-B-EU, 7C01U1-B-EU, 7C01P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:27.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-76H50TXL</udiDi>
    <basicUdiDi>B-76H50TXL</basicUdiDi>
    <tradeName>Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName>Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>76H50T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:18.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-76H50TSCVL</udiDi>
    <basicUdiDi>B-76H50TSCVL</basicUdiDi>
    <tradeName>Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName>Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>76H50TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:16.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-76H150TAX</udiDi>
    <basicUdiDi>B-76H150TAX</basicUdiDi>
    <tradeName>Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName>Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>76H150T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:14.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-76H150TSCBK</udiDi>
    <basicUdiDi>B-76H150TSCBK</basicUdiDi>
    <tradeName>Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName>Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>76H150TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:12.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3697P</udiDi>
    <basicUdiDi>B-3697P</basicUdiDi>
    <tradeName>D-3697P</tradeName>
    <deviceName>Neuron-specific Enolase Quantitative Detection KIT (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:55:11.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-35072</udiDi>
    <basicUdiDi>B-35072</basicUdiDi>
    <tradeName>D-35072</tradeName>
    <deviceName>Squamous-cell Carcinoma Quantitative Detection KIT (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030116</emdnCode>
    <emdnDescription>SQUAMOUS CELL CARCINOMA ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:36:52.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3467B</udiDi>
    <basicUdiDi>B-3467B</basicUdiDi>
    <tradeName>D-3467B</tradeName>
    <deviceName>Human Epididymis Protein 4 Quantitative Detection KIT (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030119</emdnCode>
    <emdnDescription>HUMAN EPIDIDYMIS PROTEIN 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:28:16.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-33200FE</udiDi>
    <basicUdiDi>B-33200FE</basicUdiDi>
    <tradeName>Access CEA (Reagent Pack)</tradeName>
    <deviceName>Access CEA (Reagent Pack)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:26:19.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3306U</udiDi>
    <basicUdiDi>B-3306U</basicUdiDi>
    <tradeName>D-3306U</tradeName>
    <deviceName>Cyfra21-1 Quantitative Detection KIT (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030111</emdnCode>
    <emdnDescription>CYFRA 21-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:26:18.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-32879</udiDi>
    <basicUdiDi>B-32879</basicUdiDi>
    <tradeName>D-32879</tradeName>
    <deviceName>Cancer Antigen 15-3 Quantitative Detection KIT (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:26:05.423Z</lastUpdated>
  </row>
</eudamedExport>