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<eudamedExport entity="devices">
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    <udiDi>04897036920398</udiDi>
    <basicUdiDi>B-04897036920398</basicUdiDi>
    <tradeName>04897036920398</tradeName>
    <deviceName>GenoScreen HPV-HR Screening qPCR Assay</deviceName>
    <manufacturerName>DiagCor Life Science Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000045806</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92040</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:16:36.152Z</lastUpdated>
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  <row>
    <udiDi>04897036920381</udiDi>
    <basicUdiDi>B-04897036920381</basicUdiDi>
    <tradeName>04897036920381</tradeName>
    <deviceName>GenoQuest HPV 24 Genotyping qPCR Assay (Lyophilized)</deviceName>
    <manufacturerName>DiagCor Life Science Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000045806</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041004</emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92039</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:16:35.348Z</lastUpdated>
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    <udiDi>04712803532256</udiDi>
    <basicUdiDi>B-04712803532256</basicUdiDi>
    <tradeName>ANTISURASE B-96 II (TMB)</tradeName>
    <deviceName>ANTISURASE B-96 II (TMB)</deviceName>
    <manufacturerName>General Biologicals Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000024694</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020203</emdnCode>
    <emdnDescription>HEPATITIS B SURFACE ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4SBE6</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:36.661Z</lastUpdated>
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    <udiDi>04712803531327</udiDi>
    <basicUdiDi>B-04712803531327</basicUdiDi>
    <tradeName>GB HIV Ag-Ab COMB</tradeName>
    <deviceName>GB HIV Ag-Ab COMB</deviceName>
    <manufacturerName>General Biologicals Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000024694</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030404</emdnCode>
    <emdnDescription>HIV MULTIPLE AG/AB COMBI TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4EAIC13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:35.058Z</lastUpdated>
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    <udiDi>04712803531310</udiDi>
    <basicUdiDi>B-04712803531310</basicUdiDi>
    <tradeName>GB HIV Ag-Ab COMB</tradeName>
    <deviceName>GB HIV Ag-Ab COMB</deviceName>
    <manufacturerName>General Biologicals Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000024694</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030404</emdnCode>
    <emdnDescription>HIV MULTIPLE AG/AB COMBI TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4EAIC11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:32.645Z</lastUpdated>
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    <udiDi>04712803531303</udiDi>
    <basicUdiDi>B-04712803531303</basicUdiDi>
    <tradeName>NANBASE C-96 V4.0</tradeName>
    <deviceName>NANBASE C-96 V4.0</deviceName>
    <manufacturerName>General Biologicals Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000024694</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4NAE12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:31.049Z</lastUpdated>
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  <row>
    <udiDi>04712803531211</udiDi>
    <basicUdiDi>B-04712803531211</basicUdiDi>
    <tradeName>ANTISURGEN B</tradeName>
    <deviceName>ANTISURGEN B</deviceName>
    <manufacturerName>General Biologicals Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000024694</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020202</emdnCode>
    <emdnDescription>HEPATITIS B SURFACE ANTIGEN - CONFIRMATORY</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>4SAO</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:30.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712803531297</udiDi>
    <basicUdiDi>B-04712803531297</basicUdiDi>
    <tradeName>NANBASE C-96 V4.0</tradeName>
    <deviceName>NANBASE C-96 V4.0</deviceName>
    <manufacturerName>General Biologicals Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000024694</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4NAE3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:28.650Z</lastUpdated>
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  <row>
    <udiDi>04712803531174</udiDi>
    <basicUdiDi>B-04712803531174</basicUdiDi>
    <tradeName>ANTICORASE MB-96 (TMB)</tradeName>
    <deviceName>ANTICORASE MB-96 (TMB)</deviceName>
    <manufacturerName>General Biologicals Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000024694</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020210</emdnCode>
    <emdnDescription>HEPATITIS B CORE ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4CME3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:26.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712803531181</udiDi>
    <basicUdiDi>B-04712803531181</basicUdiDi>
    <tradeName>EASE BN-96 (TMB)</tradeName>
    <deviceName>EASE BN-96 (TMB)</deviceName>
    <manufacturerName>General Biologicals Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000024694</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020299</emdnCode>
    <emdnDescription>HBV REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4BNE3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:24.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712803531167</udiDi>
    <basicUdiDi>B-04712803531167</basicUdiDi>
    <tradeName>ANTICORASE B-96 (TMB)</tradeName>
    <deviceName>ANTICORASE B-96 (TMB)</deviceName>
    <manufacturerName>General Biologicals Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000024694</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020209</emdnCode>
    <emdnDescription>HEPATITIS B CORE ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4CBE3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:10.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712803531150</udiDi>
    <basicUdiDi>B-04712803531150</basicUdiDi>
    <tradeName>ANTISURASE B-96 (TMB)</tradeName>
    <deviceName>ANTISURASE B-96 (TMB)</deviceName>
    <manufacturerName>General Biologicals Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000024694</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020203</emdnCode>
    <emdnDescription>HEPATITIS B SURFACE ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4SBE3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:09.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712803531143</udiDi>
    <basicUdiDi>B-04712803531143</basicUdiDi>
    <tradeName>SURASE B-96 (TMB)</tradeName>
    <deviceName>SURASE B-96 (TMB)</deviceName>
    <manufacturerName>General Biologicals Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000024694</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020201</emdnCode>
    <emdnDescription>HEPATITIS B SURFACE ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4SGE11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:06.975Z</lastUpdated>
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  <row>
    <udiDi>04712803531136</udiDi>
    <basicUdiDi>B-04712803531136</basicUdiDi>
    <tradeName>SURASE B-96 (TMB)</tradeName>
    <deviceName>SURASE B-96 (TMB)</deviceName>
    <manufacturerName>General Biologicals Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000024694</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020201</emdnCode>
    <emdnDescription>HEPATITIS B SURFACE ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4SGE3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:05.382Z</lastUpdated>
  </row>
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    <udiDi>04712803530016</udiDi>
    <basicUdiDi>B-04712803530016</basicUdiDi>
    <tradeName>HBV RealQuant™ PCR</tradeName>
    <deviceName>HBV RealQuant™ PCR</deviceName>
    <manufacturerName>General Biologicals Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000024694</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020299</emdnCode>
    <emdnDescription>HBV REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4HBPA2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:04.580Z</lastUpdated>
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  <row>
    <udiDi>04571226474747</udiDi>
    <basicUdiDi>B-04571226474747</basicUdiDi>
    <tradeName>Determine</tradeName>
    <deviceName>Determine HIV Controls</deviceName>
    <manufacturerName>Abbott Diagnostics Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000009543</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105094002</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS INFECTIOUS IMMUNOLOGY/NAT - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7D2253</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:56:07.879Z</lastUpdated>
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    <udiDi>04571226473832</udiDi>
    <basicUdiDi>B-04571226473832</basicUdiDi>
    <tradeName>04571226473832</tradeName>
    <deviceName>Determine HIV Early Detect</deviceName>
    <manufacturerName>Abbott Diagnostics Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000009543</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090303</emdnCode>
    <emdnDescription>HIV AG/AB COMBI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7D2846</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:56:06.164Z</lastUpdated>
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    <udiDi>04571226471784</udiDi>
    <basicUdiDi>B-04571226471784</basicUdiDi>
    <tradeName>TestPack Plus Strep A with OBC</tradeName>
    <deviceName>TestPack Plus Strep A with OBC</deviceName>
    <manufacturerName>Abbott Diagnostics Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000009543</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>505715J</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:56:01.369Z</lastUpdated>
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    <udiDi>04571226470206</udiDi>
    <basicUdiDi>B-04571226470206</basicUdiDi>
    <tradeName>Determine</tradeName>
    <deviceName>Determine Syphilis TP</deviceName>
    <manufacturerName>Abbott Diagnostics Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000009543</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7D2443</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:56:00.564Z</lastUpdated>
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    <udiDi>04562185405323</udiDi>
    <basicUdiDi>B-04562185405323</basicUdiDi>
    <tradeName>04562185405323</tradeName>
    <deviceName>TRCReady SARS-CoV-2 NE</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0056110</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:50:34.081Z</lastUpdated>
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