<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DC76038FL</udiDi>
    <basicUdiDi>B-DC76038FL</basicUdiDi>
    <tradeName>iStar-CEA</tradeName>
    <deviceName>iStar-CEA</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76038</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:24.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D-AFP-42XM</udiDi>
    <basicUdiDi>B-D-AFP-42XM</basicUdiDi>
    <tradeName>D-D-AFP-42XM</tradeName>
    <deviceName>Alpha-fetoprotein 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>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-AFP-42</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:04.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CY21-1706-AEMQ</udiDi>
    <basicUdiDi>B-CY21-1706-AEMQ</basicUdiDi>
    <tradeName>CYFRA21-1 Cytokeratin 19 Fragments (CLIA)</tradeName>
    <deviceName>CYFRA21-1 Cytokeratin 19 Fragments (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030111</emdnCode>
    <emdnDescription>CYFRA 21-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CY21-1706-AE10Y, CY21-1706-AE10N, CY21-1706-AE20Y, CY21-1706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T10:39:36.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-LA-S015UM</udiDi>
    <basicUdiDi>B-CNMF000014455-LA-S015UM</basicUdiDi>
    <tradeName>D-CNMF000014455-LA-S015UM</tradeName>
    <deviceName>Matrix Metalloproteinase-9 Test Kit (Latex Lateral Flow Assay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039010</emdnCode>
    <emdnDescription>MATRIX-METALLOPROTEINASES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LA-S015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:13:25.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-LA-S014UK</udiDi>
    <basicUdiDi>B-CNMF000014455-LA-S014UK</basicUdiDi>
    <tradeName>D-CNMF000014455-LA-S014UK</tradeName>
    <deviceName>Matrix Metalloproteinase-9 Test Kit (Latex Lateral Flow Assay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039010</emdnCode>
    <emdnDescription>MATRIX-METALLOPROTEINASES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LA-S014</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:13:24.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-LA-S013UH</udiDi>
    <basicUdiDi>B-CNMF000014455-LA-S013UH</basicUdiDi>
    <tradeName>D-CNMF000014455-LA-S013UH</tradeName>
    <deviceName>Matrix Metalloproteinase-9 Test Kit (Latex Lateral Flow Assay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039010</emdnCode>
    <emdnDescription>MATRIX-METALLOPROTEINASES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LA-S013</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:13:20.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-LA-S012UF</udiDi>
    <basicUdiDi>B-CNMF000014455-LA-S012UF</basicUdiDi>
    <tradeName>D-CNMF000014455-LA-S012UF</tradeName>
    <deviceName>Matrix Metalloproteinase-9 Test Kit (Latex Lateral Flow Assay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039010</emdnCode>
    <emdnDescription>MATRIX-METALLOPROTEINASES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LA-S012</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:13:19.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CEA706-AEJL</udiDi>
    <basicUdiDi>B-CEA706-AEJL</basicUdiDi>
    <tradeName>CEA Carcinoembryonic Antigen (CLIA)</tradeName>
    <deviceName>CEA Carcinoembryonic Antigen (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CEA706-AE10Y, CEA706-AE10N, CEA706-AE20Y, CEA706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:02:00.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CA72-4706-AE5B</udiDi>
    <basicUdiDi>B-CA72-4706-AE5B</basicUdiDi>
    <tradeName>CA72-4 Cancer Antigen 72-4 (CLIA)</tradeName>
    <deviceName>CA72-4 Cancer Antigen 72-4 (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA72-4706-AE10Y, CA72-4706-AE10N, CA72-4706-AE20Y, CA72-4706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:55:14.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CA50706-AETU</udiDi>
    <basicUdiDi>B-CA50706-AETU</basicUdiDi>
    <tradeName>CA50 Cancer Antigen 50 (CLIA)</tradeName>
    <deviceName>CA50 Cancer Antigen 50 (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030104</emdnCode>
    <emdnDescription>CANCER ANTIGEN 50</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA50706-AE10Y, CA50706-AE10N, CA50706-AE20Y, CA50706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:55:14.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CA242706-AEEK</udiDi>
    <basicUdiDi>B-CA242706-AEEK</basicUdiDi>
    <tradeName>CA242 Cancer Antigen 242 (CLIA)</tradeName>
    <deviceName>CA242 Cancer Antigen 242 (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030108</emdnCode>
    <emdnDescription>CANCER ANTIGEN 242</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA242706-AE10Y, CA242706-AE10N, CA242706-AE20Y, CA242706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:55:12.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CA15-3706-AEZE</udiDi>
    <basicUdiDi>B-CA15-3706-AEZE</basicUdiDi>
    <tradeName>CA15-3 Cancer Antigen 15-3 (CLIA)</tradeName>
    <deviceName>CA15-3 Cancer Antigen 15-3 (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA15-3706-AE10Y, CA15-3706-AE10N, CA15-3706-AE20Y, CA15-3706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:55:11.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CA125706-AEE9</udiDi>
    <basicUdiDi>B-CA125706-AEE9</basicUdiDi>
    <tradeName>CA125 Cancer Antigen 125 (CLIA)</tradeName>
    <deviceName>CA125 Cancer Antigen 125 (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA125706-AE10Y, CA125706-AE10N, CA125706-AE20Y, CA125706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:55:07.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-B2-MG601SS</udiDi>
    <basicUdiDi>B-B2-MG601SS</basicUdiDi>
    <tradeName>β2-Microglobulin Reagent Kit</tradeName>
    <deviceName>β2-Microglobulin Reagent Kit</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</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>β2-MG6011Y, β2-MG6012Y, β2-MG6013Y, β2-MG6014Y, β2-MG6015Y, β2-MG6011N, β2-MG6012N, β2-MG6013N, β2-MG6014N, β2-MG6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:49:50.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AFU6019D</udiDi>
    <basicUdiDi>B-AFU6019D</basicUdiDi>
    <tradeName>α-L-Fucosidase Reagent Kit</tradeName>
    <deviceName>α-L-Fucosidase Reagent Kit</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039018</emdnCode>
    <emdnDescription>ALPHA-FUCOSIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFU6011Y, AFU6012Y, AFU6013Y, AFU6014Y, AFU6015Y, AFU6011N, AFU6012N, AFU6013N, AFU6014N, AFU6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:33:33.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AFP706-AERQ</udiDi>
    <basicUdiDi>B-AFP706-AERQ</basicUdiDi>
    <tradeName>AFP Alpha-Fetoprotein (CLIA)</tradeName>
    <deviceName>AFP Alpha-Fetoprotein (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFP706-AE10Y, AFP706-AE10N, AFP706-AE20Y, AFP706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:33:27.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AFP-02-48tAE</udiDi>
    <basicUdiDi>B-AFP-02-48tAE</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFP-02-48t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:33:26.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-90502HE</udiDi>
    <basicUdiDi>B-90502HE</basicUdiDi>
    <tradeName>D-90502HE</tradeName>
    <deviceName>Fecal Occult Blood Rapid Test（Colloidal Gold）</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:55:12.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7M19FH</udiDi>
    <basicUdiDi>B-7M19FH</basicUdiDi>
    <tradeName>β2-Microglobulin assay (CLIA)</tradeName>
    <deviceName>β2-Microglobulin 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>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7M19V1-B-EU, 7M19U1-B-EU, 7M19P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:28:41.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7C22DL</udiDi>
    <basicUdiDi>B-7C22DL</basicUdiDi>
    <tradeName>Progastrin-Releasing Peptide assay (CLIA)</tradeName>
    <deviceName>Progastrin-Releasing Peptide 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>W0102030121</emdnCode>
    <emdnDescription>PRO-GASTRIN-RELEASING PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7C22V1-B-EU, 7C22U1-B-EU, 7C22P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:28:03.029Z</lastUpdated>
  </row>
</eudamedExport>