<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-R1601325</udiDi>
    <basicUdiDi>B-R1601325</basicUdiDi>
    <tradeName>D-R1601325</tradeName>
    <deviceName>Carcinoembryonic Antigen (CEA) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R16013</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:57.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R159163H</udiDi>
    <basicUdiDi>B-R159163H</basicUdiDi>
    <tradeName>D-R159163H</tradeName>
    <deviceName>Alpha-Fetoprotein (AFP) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15916</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:40.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R159153F</udiDi>
    <basicUdiDi>B-R159153F</basicUdiDi>
    <tradeName>D-R159153F</tradeName>
    <deviceName>Alpha-Fetoprotein (AFP) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15915</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:39.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R159143D</udiDi>
    <basicUdiDi>B-R159143D</basicUdiDi>
    <tradeName>D-R159143D</tradeName>
    <deviceName>Alpha-Fetoprotein (AFP) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15914</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:38.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R159133B</udiDi>
    <basicUdiDi>B-R159133B</basicUdiDi>
    <tradeName>D-R159133B</tradeName>
    <deviceName>Alpha-Fetoprotein (AFP) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15913</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:38.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1591239</udiDi>
    <basicUdiDi>B-R1591239</basicUdiDi>
    <tradeName>D-R1591239</tradeName>
    <deviceName>Alpha-Fetoprotein (AFP) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15912</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:33.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1591137</udiDi>
    <basicUdiDi>B-R1591137</basicUdiDi>
    <tradeName>D-R1591137</tradeName>
    <deviceName>Alpha-Fetoprotein (AFP) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030399</emdnCode>
    <emdnDescription>OTHER ONCOPROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R15911</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:33.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R058152X</udiDi>
    <basicUdiDi>B-R058152X</basicUdiDi>
    <tradeName>D-R058152X</tradeName>
    <deviceName>In vitro test for the quantitative determination of β2-Microglobulin (β2 MG) concentration in human serum.</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</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>R05815</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:54:31.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R058142V</udiDi>
    <basicUdiDi>B-R058142V</basicUdiDi>
    <tradeName>D-R058142V</tradeName>
    <deviceName>β2-microglobulin Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</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>R05814</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:54:30.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R058132T</udiDi>
    <basicUdiDi>B-R058132T</basicUdiDi>
    <tradeName>D-R058132T</tradeName>
    <deviceName>β2-microglobulin Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</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>R05813</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:54:29.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R058122R</udiDi>
    <basicUdiDi>B-R058122R</basicUdiDi>
    <tradeName>D-R058122R</tradeName>
    <deviceName>β2-microglobulin Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</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>R05812</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:54:28.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R058112P</udiDi>
    <basicUdiDi>B-R058112P</basicUdiDi>
    <tradeName>D-R058112P</tradeName>
    <deviceName>β2-microglobulin Assay Reagent Kit (Latex-Enhanced Immunoturbidimetric)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</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>R05811</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:54:24.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627008985</udiDi>
    <basicUdiDi>B-00847627008985</basicUdiDi>
    <tradeName>Folate Receptor alpha IHC Assay Kit</tradeName>
    <deviceName>Folate Receptor alpha IHC Assay Kit</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPI4006KG10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:42:20.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627005182</udiDi>
    <basicUdiDi>B-00847627005182</basicUdiDi>
    <tradeName>Folate Receptor alpha IHC Assay Kit</tradeName>
    <deviceName>Folate Receptor alpha IHC Assay Kit</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BRI4006KAA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:42:15.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673075156</udiDi>
    <basicUdiDi>B-08431673075156</basicUdiDi>
    <tradeName>FOB-TURBI</tradeName>
    <deviceName>Fecal ocult blood</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI1107186</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:33:23.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673074937</udiDi>
    <basicUdiDi>B-08431673074937</basicUdiDi>
    <tradeName>FOB-TURBI</tradeName>
    <deviceName>Fecal ocult blood</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI1107185</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:33:22.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026150846</udiDi>
    <basicUdiDi>357302BUDI000564TV</basicUdiDi>
    <tradeName>VIDAS® CEA (S)</tradeName>
    <deviceName>VIDAS® CEA (S)</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30453</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:28.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026065140</udiDi>
    <basicUdiDi>357302BUDI000242T4</basicUdiDi>
    <tradeName>VIDAS® CA 15-3®</tradeName>
    <deviceName>VIDAS® CA 15-3®</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30429</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:14.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026065119</udiDi>
    <basicUdiDi>357302BUDI000239TF</basicUdiDi>
    <tradeName>VIDAS® CA 125 II™</tradeName>
    <deviceName>VIDAS® CA 125 II™</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30426</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:13.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414196664</udiDi>
    <basicUdiDi>0405686901799WS</basicUdiDi>
    <tradeName>ADVIA Centaur BR</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_BR</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030110</emdnCode>
    <emdnDescription>CANCER ANTIGEN 27.29</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10334837</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:48:51.329Z</lastUpdated>
  </row>
</eudamedExport>