<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060515140122</udiDi>
    <basicUdiDi>506051514RPREF</basicUdiDi>
    <tradeName>Newbio RPR 100</tradeName>
    <deviceName>Newbio RPR</deviceName>
    <manufacturerName>Newmarket Biomedical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025155</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:22:54.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060515140078</udiDi>
    <basicUdiDi>506051514TPHA7L</basicUdiDi>
    <tradeName>Newbio TPHA 100</tradeName>
    <deviceName>Newbio TPHA</deviceName>
    <manufacturerName>Newmarket Biomedical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025155</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:22:54.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060515140344</udiDi>
    <basicUdiDi>506051514TPHA7L</basicUdiDi>
    <tradeName>Newbio TPHA 100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newmarket Biomedical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025155</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:52:25.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060515140306</udiDi>
    <basicUdiDi>506051514RPREF</basicUdiDi>
    <tradeName>Newbio RPR 500</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newmarket Biomedical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025155</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:52:23.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060515140290</udiDi>
    <basicUdiDi>506051514RPREF</basicUdiDi>
    <tradeName>Newbio RPR 100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newmarket Biomedical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025155</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:52:22.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060515140283</udiDi>
    <basicUdiDi>506051514TPHA7L</basicUdiDi>
    <tradeName>Newbio TPHA 1000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newmarket Biomedical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025155</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:52:20.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060515140276</udiDi>
    <basicUdiDi>506051514TPHA7L</basicUdiDi>
    <tradeName>Newbio TPHA 200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newmarket Biomedical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025155</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:52:20.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060515140139</udiDi>
    <basicUdiDi>506051514RPREF</basicUdiDi>
    <tradeName>Newbio RPR 500</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newmarket Biomedical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025155</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:52:18.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060515140108</udiDi>
    <basicUdiDi>B-05060515140108</basicUdiDi>
    <tradeName>NewBio Syphilis EIA TA - 96 Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newmarket Biomedical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025155</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:52:15.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060515140092</udiDi>
    <basicUdiDi>506051514TPHA7L</basicUdiDi>
    <tradeName>Newbio TPHA 1000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newmarket Biomedical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025155</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:52:14.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060515140085</udiDi>
    <basicUdiDi>506051514TPHA7L</basicUdiDi>
    <tradeName>Newbio TPHA 200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newmarket Biomedical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025155</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NB008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:52:12.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060515140047</udiDi>
    <basicUdiDi>B-05060515140047</basicUdiDi>
    <tradeName>PK7400 TP HA Controls</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newmarket Biomedical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025155</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B11187</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:52:10.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060515140030</udiDi>
    <basicUdiDi>B-05060515140030</basicUdiDi>
    <tradeName>PK7400 TP HA Reagent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Newmarket Biomedical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000025155</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B11186</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:52:09.284Z</lastUpdated>
  </row>
</eudamedExport>