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<eudamedExport entity="devices">
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    <udiDi>15099590211547</udiDi>
    <basicUdiDi>150995905DSL5400FA</basicUdiDi>
    <tradeName>Estrone Sulfate RIA</tradeName>
    <deviceName>Estrone Sulfate RIA</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050204</emdnCode>
    <emdnDescription>ESTRONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSL5400</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:51.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590211530</udiDi>
    <basicUdiDi>150995905DSL4900FU</basicUdiDi>
    <tradeName>ACTIVE® Free Testosterone RIA</tradeName>
    <deviceName>ACTIVE® Free Testosterone RIA</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSL4900</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:50.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590211523</udiDi>
    <basicUdiDi>150995905DSL4800FP</basicUdiDi>
    <tradeName>Ultra-Sensitive Estradiol RIA</tradeName>
    <deviceName>Ultra-Sensitive Estradiol RIA</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSL4800</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:49.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590211516</udiDi>
    <basicUdiDi>150995905DSL3800FG</basicUdiDi>
    <tradeName>ACTIVE® Androstenedione RIA</tradeName>
    <deviceName>ACTIVE® Androstenedione RIA</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050101</emdnCode>
    <emdnDescription>ANDROSTENEDIONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSL3800</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:48.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590211509</udiDi>
    <basicUdiDi>150995905DSL2700F4</basicUdiDi>
    <tradeName>DHEA-S-7 RIA</tradeName>
    <deviceName>DHEA-S-7 RIA</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSL2700</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:44.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590211486</udiDi>
    <basicUdiDi>150995905DSL25100KM</basicUdiDi>
    <tradeName>ACTIVE® Renin IRMA</tradeName>
    <deviceName>ACTIVE® Renin IRMA</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060204</emdnCode>
    <emdnDescription>RENINE (PLASMA RENINE ACTIVITY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSL25100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:43.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590211417</udiDi>
    <basicUdiDi>150995905InhibinAK9</basicUdiDi>
    <tradeName>Inhibin A ELISA</tradeName>
    <deviceName>Inhibin A ELISA</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050214</emdnCode>
    <emdnDescription>INHIBIN A/B (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSL-10-28100T</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:43.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590206840</udiDi>
    <basicUdiDi>150995905A81304SW</basicUdiDi>
    <tradeName>Inhibin B Gen II Calibrators and Controls</tradeName>
    <deviceName>Inhibin B Gen II Calibrators and Controls</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A81304</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:42.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590206833</udiDi>
    <basicUdiDi>150995905A81303SU</basicUdiDi>
    <tradeName>Inhibin B Gen II ELISA</tradeName>
    <deviceName>Inhibin B Gen II ELISA</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A81303</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:37.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590206710</udiDi>
    <basicUdiDi>150995905A79766VM</basicUdiDi>
    <tradeName>AMH Gen II Calibrators and Controls</tradeName>
    <deviceName>AMH Gen II Calibrators and Controls</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152208</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A79766</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:36.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590206703</udiDi>
    <basicUdiDi>150995905A79765VK</basicUdiDi>
    <tradeName>AMH Gen II ELISA</tradeName>
    <deviceName>AMH Gen II ELISA</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A79765</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:35.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590205355</udiDi>
    <basicUdiDi>150995905A56888UR</basicUdiDi>
    <tradeName>Cytokeratin 19 Fragment IRMA Kit</tradeName>
    <deviceName>Cytokeratin 19 Fragment IRMA Kit</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030126</emdnCode>
    <emdnDescription>CYTOKERATINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A56888</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:35.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590205348</udiDi>
    <basicUdiDi>150995905A56719TZ</basicUdiDi>
    <tradeName>Anti-TPO RIA KIT</tradeName>
    <deviceName>Anti-TPO RIA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A56719</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:31.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590203719</udiDi>
    <basicUdiDi>150995905A44176SN</basicUdiDi>
    <tradeName>Ostase IRMA KIT</tradeName>
    <deviceName>Ostase IRMA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060318</emdnCode>
    <emdnDescription>BONE ALKALINE PHOSPHATASE (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A44176</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:30.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590203139</udiDi>
    <basicUdiDi>150995905A37404SN</basicUdiDi>
    <tradeName>AFP screening IRMA KIT</tradeName>
    <deviceName>AFP screening IRMA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050299</emdnCode>
    <emdnDescription>PREGNANCY TESTING HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A37404</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:29.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590202545</udiDi>
    <basicUdiDi>150995905A30282RF</basicUdiDi>
    <tradeName>T3 Uptake RIA KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01020406</emdnCode>
    <emdnDescription>T- UPTAKE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A30282</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:27.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590202132</udiDi>
    <basicUdiDi>150995905E2RIA7Y</basicUdiDi>
    <tradeName>RIA Estradiol</tradeName>
    <deviceName>RIA Estradiol</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A21854, B89462</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:23.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590201777</udiDi>
    <basicUdiDi>150995905A15729SH</basicUdiDi>
    <tradeName>IRMA IGF-I</tradeName>
    <deviceName>IRMA IGF-I</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060403</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR I (SOMATOMEDIN C)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A15729</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:23.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590201708</udiDi>
    <basicUdiDi>150995905A15607S2</basicUdiDi>
    <tradeName>NSE IRMA KIT</tradeName>
    <deviceName>NSE IRMA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A15607</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:22.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590201517</udiDi>
    <basicUdiDi>150995905PTHIRMAYZ</basicUdiDi>
    <tradeName>IRMA PTH</tradeName>
    <deviceName>IRMA PTH</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060312</emdnCode>
    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11930, B89461</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:52:21.590Z</lastUpdated>
  </row>
</eudamedExport>