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<eudamedExport entity="devices">
  <row>
    <udiDi>08588007926155</udiDi>
    <basicUdiDi>B-08588007926155</basicUdiDi>
    <tradeName>08588007926155</tradeName>
    <deviceName>NITROCEFIN</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2008</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:23:24.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>08588007926148</udiDi>
    <basicUdiDi>B-08588007926148</basicUdiDi>
    <tradeName>08588007926148</tradeName>
    <deviceName>INDOXYL</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2007</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:23:23.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>08588007926131</udiDi>
    <basicUdiDi>B-08588007926131</basicUdiDi>
    <tradeName>08588007926131</tradeName>
    <deviceName>HIP</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2006</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:23:22.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>08588007926124</udiDi>
    <basicUdiDi>B-08588007926124</basicUdiDi>
    <tradeName>08588007926124</tradeName>
    <deviceName>ONP</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2005</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:23:20.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>08588007926117</udiDi>
    <basicUdiDi>B-08588007926117</basicUdiDi>
    <tradeName>08588007926117</tradeName>
    <deviceName>VP</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2004</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:23:18.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>08588007926100</udiDi>
    <basicUdiDi>B-08588007926100</basicUdiDi>
    <tradeName>08588007926100</tradeName>
    <deviceName>PYR</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2003</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:23:16.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>08588007926094</udiDi>
    <basicUdiDi>B-08588007926094</basicUdiDi>
    <tradeName>08588007926094</tradeName>
    <deviceName>COLI</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2002</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:23:16.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>08588007926087</udiDi>
    <basicUdiDi>B-08588007926087</basicUdiDi>
    <tradeName>08588007926087</tradeName>
    <deviceName>OXI</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2001</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:23:14.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>08588007926063</udiDi>
    <basicUdiDi>B-08588007926063</basicUdiDi>
    <tradeName>08588007926063</tradeName>
    <deviceName>NEISS 8</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080299</emdnCode>
    <emdnDescription>MANUAL IDENTIFICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1004</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:23:10.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>08588007926056</udiDi>
    <basicUdiDi>B-08588007926056</basicUdiDi>
    <tradeName>08588007926056</tradeName>
    <deviceName>ENC 8</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080203</emdnCode>
    <emdnDescription>GRAM POSITIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1003</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:23:09.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>08588007926032</udiDi>
    <basicUdiDi>B-08588007926032</basicUdiDi>
    <tradeName>08588007926032</tradeName>
    <deviceName>GP 24</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080203</emdnCode>
    <emdnDescription>GRAM POSITIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1002</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:23:08.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>08588007926018</udiDi>
    <basicUdiDi>B-08588007926018</basicUdiDi>
    <tradeName>08588007926018</tradeName>
    <deviceName>GN 24</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080201</emdnCode>
    <emdnDescription>GRAM NEGATIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:23:07.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975400320048</udiDi>
    <basicUdiDi>B-06975400320048</basicUdiDi>
    <tradeName>VIUICK</tradeName>
    <deviceName>Diagnostic Kit for Ureaplasma Urealyticum DNA (Real-Time PCR Method)</deviceName>
    <manufacturerName>Guangzhou Viuick Biotechnology Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000017369</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080207</emdnCode>
    <emdnDescription>MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:30:51.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674893210</udiDi>
    <basicUdiDi>B-06974674893210</basicUdiDi>
    <tradeName>Mycoplasma Pheumonia IgG (MP IgG) Detection Kit(CLIA)</tradeName>
    <deviceName>Mycoplasma Pheumonia IgG (MP IgG) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080207</emdnCode>
    <emdnDescription>MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0193</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:31.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892404</udiDi>
    <basicUdiDi>B-06974674892404</basicUdiDi>
    <tradeName>MP IgM FIA Kit</tradeName>
    <deviceName>MP IgM FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080207</emdnCode>
    <emdnDescription>MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0070</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:21.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974674892398</udiDi>
    <basicUdiDi>B-06974674892398</basicUdiDi>
    <tradeName>MP IgG FIA Kit</tradeName>
    <deviceName>MP IgG FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080207</emdnCode>
    <emdnDescription>MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP IgG FIA Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:20.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595142262901</udiDi>
    <basicUdiDi>85951422496209T</basicUdiDi>
    <tradeName>ZELEŇ MALACHITOVÁ indikátor</tradeName>
    <deviceName>ZELEŇ MALACHITOVÁ indikátor</deviceName>
    <manufacturerName>Ing. Petr Švec - PENTA s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000035988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080299</emdnCode>
    <emdnDescription>MANUAL IDENTIFICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28500-30010</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:55:50.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595142257204</udiDi>
    <basicUdiDi>85951422209307Q</basicUdiDi>
    <tradeName>LÖFFLER ROZTOK</tradeName>
    <deviceName>LÖFFLER ROZTOK</deviceName>
    <manufacturerName>Ing. Petr Švec - PENTA s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000035988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080299</emdnCode>
    <emdnDescription>MANUAL IDENTIFICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20930-11000</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:55:43.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595142250601</udiDi>
    <basicUdiDi>85951422235407U</basicUdiDi>
    <tradeName>PANDY ROZTOK</tradeName>
    <deviceName>PANDY ROZTOK</deviceName>
    <manufacturerName>Ing. Petr Švec - PENTA s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000035988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080299</emdnCode>
    <emdnDescription>MANUAL IDENTIFICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23540-11000</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:55:23.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595142250007</udiDi>
    <basicUdiDi>85951422146307S</basicUdiDi>
    <tradeName>GRAM IV roztok</tradeName>
    <deviceName>GRAM IV ROZTOK</deviceName>
    <manufacturerName>Ing. Petr Švec - PENTA s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000035988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080201</emdnCode>
    <emdnDescription>GRAM NEGATIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14630</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:55:12.584Z</lastUpdated>
  </row>
</eudamedExport>