<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-R226132J</udiDi>
    <basicUdiDi>B-R226132J</basicUdiDi>
    <tradeName>D-R226132J</tradeName>
    <deviceName>Astroglial Protein S100-β (S100-β) 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>W0102010399</emdnCode>
    <emdnDescription>TRANSPORT PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22613</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:09:08.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R226122G</udiDi>
    <basicUdiDi>B-R226122G</basicUdiDi>
    <tradeName>D-R226122G</tradeName>
    <deviceName>Astroglial Protein S100-β (S100-β) 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>W0102010399</emdnCode>
    <emdnDescription>TRANSPORT PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22612</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:09:07.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R226152N</udiDi>
    <basicUdiDi>B-R226152N</basicUdiDi>
    <tradeName>D-R226152N</tradeName>
    <deviceName>Astroglial Protein S100-β (S100-β) 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>W0102010399</emdnCode>
    <emdnDescription>TRANSPORT PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22615</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:09:07.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R226142L</udiDi>
    <basicUdiDi>B-R226142L</basicUdiDi>
    <tradeName>D-R226142L</tradeName>
    <deviceName>Astroglial Protein S100-β (S100-β) 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>W0102010399</emdnCode>
    <emdnDescription>TRANSPORT PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22614</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:09:06.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R226112E</udiDi>
    <basicUdiDi>B-R226112E</basicUdiDi>
    <tradeName>D-R226112E</tradeName>
    <deviceName>Astroglial Protein S100-β (S100-β) 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>W0102010399</emdnCode>
    <emdnDescription>TRANSPORT PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R22611</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:08:48.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-127FL</udiDi>
    <basicUdiDi>B-6-127FL</basicUdiDi>
    <tradeName>D-6-127FL</tradeName>
    <deviceName>Neutrophil gelatinase-associated lipocalin (NGAL)Test Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010399</emdnCode>
    <emdnDescription>TRANSPORT PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USCA00000722, USCA00000725 USCA00000723, USCA00000724 USCA00000726, USCA00000771"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:08:28.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-475100PY</udiDi>
    <basicUdiDi>B-475100PY</basicUdiDi>
    <tradeName>Microalbumin Reagent (MA 2 x 100)</tradeName>
    <deviceName>Microalbumin Reagent (MA 2 x 100)</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>W0102010399</emdnCode>
    <emdnDescription>TRANSPORT PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>475100</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:06:07.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598014619</udiDi>
    <basicUdiDi>4050598MNTRELXY</basicUdiDi>
    <tradeName>selenOtest ELISA</tradeName>
    <deviceName>selenOtest ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010399</emdnCode>
    <emdnDescription>TRANSPORT PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YC5900</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:16:30.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289810302</udiDi>
    <basicUdiDi>B-06933289810302</basicUdiDi>
    <tradeName>Finecare</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010399</emdnCode>
    <emdnDescription>TRANSPORT PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W228</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:05:55.831Z</lastUpdated>
  </row>
</eudamedExport>