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<eudamedExport entity="devices">
  <row>
    <udiDi>04262420431062</udiDi>
    <basicUdiDi>426242043ELISA2L</basicUdiDi>
    <tradeName>STEM35-ELISA Washing Buffer</tradeName>
    <deviceName>STEM35-ELISA Washing Buffer</deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>STEM35</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:32:48.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430850</udiDi>
    <basicUdiDi>426242043STEM9E</basicUdiDi>
    <tradeName>STEM33-ELISA Coating Buffer</tradeName>
    <deviceName>STEM33-ELISA Coating Buffer</deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>STEM33</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:32:47.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430829</udiDi>
    <basicUdiDi>426242043DNARNA25</basicUdiDi>
    <tradeName>SB0179-Genekam Universal DNA/RNA-Isolation Kit (INT)</tradeName>
    <deviceName>SB0179-Genekam Universal DNA/RNA-Isolation Kit (INT)</deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SB0179</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:32:43.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430799</udiDi>
    <basicUdiDi>426242043RNAISO7R</basicUdiDi>
    <tradeName>SB0079-Genekam Universal RNA-Isolation Kit (INT)</tradeName>
    <deviceName>SB0079-Genekam Universal RNA-Isolation Kit (INT)</deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SB0079</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:32:43.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430706</udiDi>
    <basicUdiDi>426242043DNAISO23</basicUdiDi>
    <tradeName>SB0001-Genekam Universal DNA-Isolation Kit (INT)</tradeName>
    <deviceName>SB0001-Genekam Universal DNA-Isolation Kit (INT)</deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SB0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:32:42.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430225</udiDi>
    <basicUdiDi>426242043GEN111SF</basicUdiDi>
    <tradeName>FR118-Human specific DNA-Internal Control (Realtime PCR-Kit)</tradeName>
    <deviceName>FR118-Human specific DNA-Internal Control (Realtime PCR-Kit)</deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080908</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR118</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:32:41.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430010</udiDi>
    <basicUdiDi>426242043GEN222SR</basicUdiDi>
    <tradeName>FR799</tradeName>
    <deviceName>FR799-Identification of human specific ß-Actin</deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080908</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR799</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:32:37.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430041</udiDi>
    <basicUdiDi>B-04262420430041</basicUdiDi>
    <tradeName>FR166-Yellow Fever Virus -(Realtime PCR-Kit)</tradeName>
    <deviceName>FR166-Yellow Fever Virus -(Realtime PCR-Kit)</deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR166</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:56:14.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430287</udiDi>
    <basicUdiDi>B-04262420430287</basicUdiDi>
    <tradeName>FR001-Leptospira pathogenic (Realtime PCR-Kit)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LEPTOSPIRA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:06:11.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430317</udiDi>
    <basicUdiDi>B-04262420430317</basicUdiDi>
    <tradeName>FR015-Epstein-Barr Virus (Ready to use Realtime PCR-Kit)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:06:11.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430379</udiDi>
    <basicUdiDi>B-04262420430379</basicUdiDi>
    <tradeName>K025-Identification of human specific DNA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:06:10.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430409</udiDi>
    <basicUdiDi>B-04262420430409</basicUdiDi>
    <tradeName>K019-FactorV / Prothrombin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:06:10.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430430</udiDi>
    <basicUdiDi>B-04262420430430</basicUdiDi>
    <tradeName>K740-Detection of Borrelia burgdorferi</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LYME DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K740</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:06:10.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430461</udiDi>
    <basicUdiDi>B-04262420430461</basicUdiDi>
    <tradeName>K017a-Leptospira pathogenic (Ready to use PCR-Kit)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LEPTOSPIRA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K017a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:06:10.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430492</udiDi>
    <basicUdiDi>B-04262420430492</basicUdiDi>
    <tradeName>K011-Mycoplasma pneumoniae (Ready to use PCR-Kit)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:06:10.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430522</udiDi>
    <basicUdiDi>B-04262420430522</basicUdiDi>
    <tradeName>K012-Mycoplasma genitalium (Ready to use PCR-Kit)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:06:10.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430553</udiDi>
    <basicUdiDi>B-04262420430553</basicUdiDi>
    <tradeName>K068-Ureaplasma urealyticum (Ready to use PCR-Kit)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K068</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:06:10.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430584</udiDi>
    <basicUdiDi>B-04262420430584</basicUdiDi>
    <tradeName>K063-Brucella abortus-Ready to use PCR-Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BRUCELLA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:06:10.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430614</udiDi>
    <basicUdiDi>B-04262420430614</basicUdiDi>
    <tradeName>K201-Plasmodium falciparum</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:06:10.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430645</udiDi>
    <basicUdiDi>B-04262420430645</basicUdiDi>
    <tradeName>K404-Plasmodium vivax</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K404</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:06:10.814Z</lastUpdated>
  </row>
</eudamedExport>