<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04931921899496</udiDi>
    <basicUdiDi>4931921IVD0020NP</basicUdiDi>
    <tradeName>Celltac chemi Rinse solution RN-410V</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T561</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:23:18.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562185395594</udiDi>
    <basicUdiDi>45601892100010046Y</basicUdiDi>
    <tradeName>CL AIA-PACK WASH CONCENTRATE</tradeName>
    <deviceName>CL AIA-PACK WASH CONCENTRATE</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029703</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:01:10.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560189216150</udiDi>
    <basicUdiDi>45601892100010036W</basicUdiDi>
    <tradeName>CL AIA-PACK SUBSTRATE SET</tradeName>
    <deviceName>CL AIA-PACK SUBSTRATE SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029709</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:58:46.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560189213630</udiDi>
    <basicUdiDi>456018921000100572</basicUdiDi>
    <tradeName>CL AIA-PACK DILUENT CONCENTRATE</tradeName>
    <deviceName>CL AIA-PACK DILUENT CONCENTRATE</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029708</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:58:45.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560189211742</udiDi>
    <basicUdiDi>456018921000006277</basicUdiDi>
    <tradeName>AIA-PACK SUBSTRATE SET II</tradeName>
    <deviceName>AIA-PACK SUBSTRATE SET II</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020968</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:58:44.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420431062</udiDi>
    <basicUdiDi>426242043ELISA2L</basicUdiDi>
    <tradeName>STEM35-ELISA Washing Buffer</tradeName>
    <deviceName>STEM35-ELISA Washing Buffer</deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STEM35</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:32:48.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430850</udiDi>
    <basicUdiDi>426242043STEM9E</basicUdiDi>
    <tradeName>STEM33-ELISA Coating Buffer</tradeName>
    <deviceName>STEM33-ELISA Coating Buffer</deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STEM33</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:32:47.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260152080206</udiDi>
    <basicUdiDi>4260152080204C</basicUdiDi>
    <tradeName>ScheBo Extraction Buffer</tradeName>
    <deviceName>ScheBo Extraction Buffer</deviceName>
    <manufacturerName>ScheBo Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000024072</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:31:41.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260152080305</udiDi>
    <basicUdiDi>4260152080304F</basicUdiDi>
    <tradeName>Sample/Washing Buffer 5x</tradeName>
    <deviceName>Sample/Washing Buffer 5x</deviceName>
    <manufacturerName>ScheBo Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000024072</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:31:39.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251342609512</udiDi>
    <basicUdiDi>42513426CCDSolutionY7</basicUdiDi>
    <tradeName>CCD-blocking solution</tradeName>
    <deviceName>CCD-blocking solution</deviceName>
    <manufacturerName>MEDIWISS ANALYTIC GmbH Gesellschaft für angewandte in-vitro Analytik</manufacturerName>
    <manufacturerSrn>DE-MF-000004992</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0951</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:01:02.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250289513500</udiDi>
    <basicUdiDi>42502895BLOTSAllergyCCD7D</basicUdiDi>
    <tradeName>AESKUBLOTS® Allergy CCD Blocker</tradeName>
    <deviceName>AESKUBLOTS® Allergy CCD Blocker</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>420000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:57:06.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>03607360046425</udiDi>
    <basicUdiDi>3607364642BUEC</basicUdiDi>
    <tradeName>HYDRASHIFT 2/4 isatuximab (40 TESTS)</tradeName>
    <deviceName>HYDRASHIFT 2/4 isatuximab (40 TESTS)</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4642</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:09:29.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>03607360046395</udiDi>
    <basicUdiDi>3607364639BUF8</basicUdiDi>
    <tradeName>HYDRASHIFT 2/4 daratumumab (20 TESTS)</tradeName>
    <deviceName>HYDRASHIFT 2/4 daratumumab (20 TESTS)</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4639</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:09:28.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026551469</udiDi>
    <basicUdiDi>357302BUDI000500T3</basicUdiDi>
    <tradeName>VIDAS® Serum Free</tradeName>
    <deviceName>VIDAS® Serum Free</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>540350</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:53:06.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590224301</udiDi>
    <basicUdiDi>150995901AccVB12X8</basicUdiDi>
    <tradeName>Access Vitamin B12 Reagent Pack</tradeName>
    <deviceName>Access Vitamin B12 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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:33:54.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590233242</udiDi>
    <basicUdiDi>150995901447480LH</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447480</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:25:18.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590221188</udiDi>
    <basicUdiDi>150995901447620L9</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems ASO Anti-Streptolysin O Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems ASO Anti-Streptolysin O Reagent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447620</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:24:30.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627014511</udiDi>
    <basicUdiDi>08476270BWASHBUF3Q</basicUdiDi>
    <tradeName>ONCORE Pro Wash Buffer</tradeName>
    <deviceName>Wash Buffers for IHC</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPRI6012MM</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:59.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627014191</udiDi>
    <basicUdiDi>08476270BAGRETFS</basicUdiDi>
    <tradeName>Borg Decloaker, RTU</tradeName>
    <deviceName>Antigen Retrieval Reagent for IHC</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD1000G1</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:57.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627014184</udiDi>
    <basicUdiDi>08476270BDEPARFK</basicUdiDi>
    <tradeName>Aqua DePar, 10X</tradeName>
    <deviceName>Aqua Depar, 10X</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADP1002 M</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:53.565Z</lastUpdated>
  </row>
</eudamedExport>