<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>04260658559947</udiDi>
    <basicUdiDi>B-04260658559947</basicUdiDi>
    <tradeName>Atlas RPR Carbon Antigen Reagent, 5 ml/Vial, 1 Vial/Box.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.18.2.0005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:36:09.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658558285</udiDi>
    <basicUdiDi>B-04260658558285</basicUdiDi>
    <tradeName>Atlas</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.04.43.0.0050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:36:06.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658557455</udiDi>
    <basicUdiDi>B-04260658557455</basicUdiDi>
    <tradeName>RPR Carbon Antigen Kit, 100 Tests (2 ml Reagent, 2x0.5 ml Controls, White Glass slide, Stirring sticks).</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.18.2.0100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:35:59.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658551538</udiDi>
    <basicUdiDi>B-04260658551538</basicUdiDi>
    <tradeName>Atlas</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.04.41.0.0020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:34:36.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658551248</udiDi>
    <basicUdiDi>B-04260658551248</basicUdiDi>
    <tradeName>Atlas VDRL Kit , 2500 Tests</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.20.0.2500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:34:15.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658551224</udiDi>
    <basicUdiDi>B-04260658551224</basicUdiDi>
    <tradeName>Atlas TPHA Kit, 200 Tests</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.19.0.0200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:34:14.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658551194</udiDi>
    <basicUdiDi>B-04260658551194</basicUdiDi>
    <tradeName>Atlas RPR Carbon Antigen Kit, 100 Tests</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.18.0.0100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:34:13.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658550821</udiDi>
    <basicUdiDi>B-04260658550821</basicUdiDi>
    <tradeName>Atlas RPR Carbon Antigen Kit, 500 Tests (10 ml Reagent, 2x1 ml Controls, Stirring sticks, White Glass Slide).</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.18.7.0500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:33:55.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260658550722</udiDi>
    <basicUdiDi>B-04260658550722</basicUdiDi>
    <tradeName>Atlas TPHA Kit, 100 Tests</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010399</emdnCode>
    <emdnDescription>SYPHILIS REAGENTS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.00.19.0.0100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:33:49.618Z</lastUpdated>
  </row>
</eudamedExport>