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    <basicUdiDi>B-04099466111425</basicUdiDi>
    <tradeName>04099466111425</tradeName>
    <deviceName>Serazym® H. pylori 2nd Gen.</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:46.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>04099466110732</udiDi>
    <basicUdiDi>B-04099466110732</basicUdiDi>
    <tradeName>04099466110732</tradeName>
    <deviceName>Serazym® Clostridium difficile GDH</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011801</emdnCode>
    <emdnDescription>C.DIFFICILE GDH DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-107</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:43.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>04099466110510</udiDi>
    <basicUdiDi>B-04099466110510</basicUdiDi>
    <tradeName>04099466110510</tradeName>
    <deviceName>Serazym® RF IgA/IgG/IgM</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-105</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:42.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>04099466110015</udiDi>
    <basicUdiDi>B-04099466110015</basicUdiDi>
    <tradeName>04099466110015</tradeName>
    <deviceName>Serazym® Nucleo ANA screen plus</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:41.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>04099466109330</udiDi>
    <basicUdiDi>B-04099466109330</basicUdiDi>
    <tradeName>04099466109330</tradeName>
    <deviceName>Serazym® Campylobacter</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011401</emdnCode>
    <emdnDescription>CAMPYLOBACTER DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-093</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:38.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>04099466106131</udiDi>
    <basicUdiDi>B-04099466106131</basicUdiDi>
    <tradeName>04099466106131</tradeName>
    <deviceName>Serazym® Norovirus</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040616</emdnCode>
    <emdnDescription>NOROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-061</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:37.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>04099466105813</udiDi>
    <basicUdiDi>B-04099466105813</basicUdiDi>
    <tradeName>04099466105813</tradeName>
    <deviceName>Serazym® Anti-dsDNA IgG</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100105</emdnCode>
    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-058</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:37.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>04099466105417</udiDi>
    <basicUdiDi>B-04099466105417</basicUdiDi>
    <tradeName>04099466105417</tradeName>
    <deviceName>Serazym® Anti-Cardiolipin-ß2-GP-1 IgG/IgM</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100503</emdnCode>
    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-054</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:33.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>04099466104915</udiDi>
    <basicUdiDi>B-04099466104915</basicUdiDi>
    <tradeName>04099466104915</tradeName>
    <deviceName>Serazym® Anti-Francisella tularensis</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-049</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:32.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>04099466104533</udiDi>
    <basicUdiDi>B-04099466104533</basicUdiDi>
    <tradeName>04099466104533</tradeName>
    <deviceName>Serazym® Astrovirus</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040629</emdnCode>
    <emdnDescription>ASTROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:32.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>04099466104038</udiDi>
    <basicUdiDi>B-04099466104038</basicUdiDi>
    <tradeName>04099466104038</tradeName>
    <deviceName>Serazym® Clostridium difficile Toxin A+B</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011802</emdnCode>
    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:27.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>04099466103925</udiDi>
    <basicUdiDi>B-04099466103925</basicUdiDi>
    <tradeName>04099466103925</tradeName>
    <deviceName>Serazym® Cryptosporidium parvum</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050207</emdnCode>
    <emdnDescription>CRYPTOSPORIDIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-039</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:38:04.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>04099466360212</udiDi>
    <basicUdiDi>4099466SPPLATEEZ</basicUdiDi>
    <tradeName>04099466360212</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP-PLATE-D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T11:06:18.161Z</lastUpdated>
  </row>
</eudamedExport>