<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00630414599007</udiDi>
    <basicUdiDi>0405686901709VX</basicUdiDi>
    <tradeName>Atellica IM Fol DTT/REL (releasing agent)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_Folate DTT / Releasing Agent</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995576</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:14:40.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414598987</udiDi>
    <basicUdiDi>0405686901558W2</basicUdiDi>
    <tradeName>Atellica IM Fol DIL (diluent)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_Folate Diluent</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995574</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:14:32.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414598871</udiDi>
    <basicUdiDi>0405686901536VQ</basicUdiDi>
    <tradeName>Atellica IM Enhanced Estradiol Diluent (eE2 DIL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_KIT_eE2 Diluent</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995563</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:14:32.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414597690</udiDi>
    <basicUdiDi>0405686901557VY</basicUdiDi>
    <tradeName>Atellica IM RBC Fol (ascorbic acid/diluent)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_Fol Ascorbic Acid/Ascorbic Acid Dil</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995440</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:14:17.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-600401MT</udiDi>
    <basicUdiDi>B-600401MT</basicUdiDi>
    <tradeName>D-600401MT</tradeName>
    <deviceName>Schnelltest Gesunder Darm</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>600401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:15:30.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-600400MR</udiDi>
    <basicUdiDi>B-600400MR</basicUdiDi>
    <tradeName>D-600400MR</tradeName>
    <deviceName>Gesunder Darm</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>600400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:15:29.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-569793559221729W</udiDi>
    <basicUdiDi>B-569793559221729W</basicUdiDi>
    <tradeName>D-569793559221729W</tradeName>
    <deviceName>Urine  Reagent   Strips(Dry Chemical Method)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 piece/bag x 100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:48:15.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>50604724627496</udiDi>
    <basicUdiDi>B-50604724627496</basicUdiDi>
    <tradeName>50604724627496</tradeName>
    <deviceName>S.boydii 1-15 2.0 ml</deviceName>
    <manufacturerName>Pro-Lab Diagnostics UK</manufacturerName>
    <manufacturerSrn>GB-MF-000003833</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL.6903</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:22:39.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>50604724627328</udiDi>
    <basicUdiDi>B-50604724627328</basicUdiDi>
    <tradeName>50604724627328</tradeName>
    <deviceName>S.dysenteriae 1-10 2.0 ml</deviceName>
    <manufacturerName>Pro-Lab Diagnostics UK</manufacturerName>
    <manufacturerSrn>GB-MF-000003833</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL.6902</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:22:38.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>50604724627250</udiDi>
    <basicUdiDi>B-50604724627250</basicUdiDi>
    <tradeName>50604724627250</tradeName>
    <deviceName>S.flexneri 1-6 X&amp;Y 2.0 ml</deviceName>
    <manufacturerName>Pro-Lab Diagnostics UK</manufacturerName>
    <manufacturerSrn>GB-MF-000003833</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL.6901</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:22:38.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>50604724627182</udiDi>
    <basicUdiDi>B-50604724627182</basicUdiDi>
    <tradeName>50604724627182</tradeName>
    <deviceName>S.sonnei Phase 1 &amp; 2 2.0 ml</deviceName>
    <manufacturerName>Pro-Lab Diagnostics UK</manufacturerName>
    <manufacturerSrn>GB-MF-000003833</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL.6900</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:22:33.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>50604724627014</udiDi>
    <basicUdiDi>B-50604724627014</basicUdiDi>
    <tradeName>Factor z6</tradeName>
    <deviceName>Factor z6</deviceName>
    <manufacturerName>Pro-Lab Diagnostics UK</manufacturerName>
    <manufacturerSrn>GB-MF-000003833</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL.6157</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:22:32.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>50604724626956</udiDi>
    <basicUdiDi>B-50604724626956</basicUdiDi>
    <tradeName>Factor 7</tradeName>
    <deviceName>Factor 7</deviceName>
    <manufacturerName>Pro-Lab Diagnostics UK</manufacturerName>
    <manufacturerSrn>GB-MF-000003833</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL.6156</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:22:32.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>50604724626888</udiDi>
    <basicUdiDi>B-50604724626888</basicUdiDi>
    <tradeName>Factor 6</tradeName>
    <deviceName>Factor 6</deviceName>
    <manufacturerName>Pro-Lab Diagnostics UK</manufacturerName>
    <manufacturerSrn>GB-MF-000003833</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL.6155</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:22:31.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>50604724626710</udiDi>
    <basicUdiDi>B-50604724626710</basicUdiDi>
    <tradeName>Factor 5</tradeName>
    <deviceName>Factor 5</deviceName>
    <manufacturerName>Pro-Lab Diagnostics UK</manufacturerName>
    <manufacturerSrn>GB-MF-000003833</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL.6154</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:22:28.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>50604724626642</udiDi>
    <basicUdiDi>B-50604724626642</basicUdiDi>
    <tradeName>Factor 2</tradeName>
    <deviceName>Factor 2</deviceName>
    <manufacturerName>Pro-Lab Diagnostics UK</manufacturerName>
    <manufacturerSrn>GB-MF-000003833</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL.6153</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:22:28.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>50604724626574</udiDi>
    <basicUdiDi>B-50604724626574</basicUdiDi>
    <tradeName>Factor z29</tradeName>
    <deviceName>Factor z29</deviceName>
    <manufacturerName>Pro-Lab Diagnostics UK</manufacturerName>
    <manufacturerSrn>GB-MF-000003833</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL.6151</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:22:27.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>50604724626406</udiDi>
    <basicUdiDi>B-50604724626406</basicUdiDi>
    <tradeName>Factor z10</tradeName>
    <deviceName>Factor z10</deviceName>
    <manufacturerName>Pro-Lab Diagnostics UK</manufacturerName>
    <manufacturerSrn>GB-MF-000003833</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL.6149</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:22:25.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>50604724626338</udiDi>
    <basicUdiDi>B-50604724626338</basicUdiDi>
    <tradeName>Factor z32</tradeName>
    <deviceName>Factor z32</deviceName>
    <manufacturerName>Pro-Lab Diagnostics UK</manufacturerName>
    <manufacturerSrn>GB-MF-000003833</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL.6148</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:22:20.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>50604724626260</udiDi>
    <basicUdiDi>B-50604724626260</basicUdiDi>
    <tradeName>Factor z24</tradeName>
    <deviceName>Factor z24</deviceName>
    <manufacturerName>Pro-Lab Diagnostics UK</manufacturerName>
    <manufacturerSrn>GB-MF-000003833</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01029001</emdnCode>
    <emdnDescription>ANTISERA (MONOVALENT AND POLYVALENT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL.6147</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:22:19.687Z</lastUpdated>
  </row>
</eudamedExport>