<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08435440205166</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CDAP6</basicUdiDi>
    <tradeName>VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CDA106L</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:14:41.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440228387</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CDAP6</basicUdiDi>
    <tradeName>VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CDA101L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:52:04.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440228394</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CDAP6</basicUdiDi>
    <tradeName>VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CDA101H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:52:03.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440205197</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CDAP6</basicUdiDi>
    <tradeName>VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CDA106H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:52:02.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440205173</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CDAP6</basicUdiDi>
    <tradeName>VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CDA112L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:52:01.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440205203</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CDAP6</basicUdiDi>
    <tradeName>VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CDA112H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:52:00.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440205180</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CDAP6</basicUdiDi>
    <tradeName>VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CDA113L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:59.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440205210</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CDAP6</basicUdiDi>
    <tradeName>VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CDA113H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:57.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440216483</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CDAP6</basicUdiDi>
    <tradeName>VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CDA196T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:49.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440228479</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CDAP6</basicUdiDi>
    <tradeName>VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CDA101LE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:48.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440228448</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CDAP6</basicUdiDi>
    <tradeName>VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CDA101HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:47.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440228486</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CDAP6</basicUdiDi>
    <tradeName>VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CDA106LE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:47.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440213390</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CDAP6</basicUdiDi>
    <tradeName>VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CDA106HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:46.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440228493</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CDAP6</basicUdiDi>
    <tradeName>VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CDA112LE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:45.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440228455</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CDAP6</basicUdiDi>
    <tradeName>VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CDA112HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:44.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440228509</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CDAP6</basicUdiDi>
    <tradeName>VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CDA113LE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:43.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440228462</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CDAP6</basicUdiDi>
    <tradeName>VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CDA113HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:35.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440223382</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CDAP6</basicUdiDi>
    <tradeName>VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CDA196TE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:34.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>01220000260061</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260061</tradeName>
    <deviceName>NATtrol™ Chlamydia trachomatis Positive Control Pack</deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATCSO-6MC-IVD</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:33:16.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>01220000260054</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260054</tradeName>
    <deviceName>NATtrol™ Chlamydia trachomatis Positive Control Pack</deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATCDI-6MC-IVD</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:15:30.858Z</lastUpdated>
  </row>
</eudamedExport>