<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08435440217084</udiDi>
    <basicUdiDi>84354402_MDXRESPB_GAS4V</basicUdiDi>
    <tradeName>VIASURE Group A Streptococcus 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>W0105011103</emdnCode>
    <emdnDescription>STREP. A DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-GAS106HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-05T19:49:38.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440217091</udiDi>
    <basicUdiDi>84354402_MDXRESPB_GAS4V</basicUdiDi>
    <tradeName>VIASURE Group A Streptococcus 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>W0105011103</emdnCode>
    <emdnDescription>STREP. A DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-GAS112LE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-05T19:49:19.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440217107</udiDi>
    <basicUdiDi>84354402_MDXRESPB_GAS4V</basicUdiDi>
    <tradeName>VIASURE Group A Streptococcus 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>W0105011103</emdnCode>
    <emdnDescription>STREP. A DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-GAS112HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-05T19:49:17.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440217114</udiDi>
    <basicUdiDi>84354402_MDXRESPB_GAS4V</basicUdiDi>
    <tradeName>VIASURE Group A Streptococcus 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>W0105011103</emdnCode>
    <emdnDescription>STREP. A DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-GAS113LE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-05T19:49:05.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440217121</udiDi>
    <basicUdiDi>84354402_MDXRESPB_GAS4V</basicUdiDi>
    <tradeName>VIASURE Group A Streptococcus 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>W0105011103</emdnCode>
    <emdnDescription>STREP. A DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-GAS113HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-05T19:49:03.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440217169</udiDi>
    <basicUdiDi>84354402_MDXRESPB_GAS4V</basicUdiDi>
    <tradeName>VIASURE Group A Streptococcus 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>W0105011103</emdnCode>
    <emdnDescription>STREP. A DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-GAS196TE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-05T19:49:02.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440217138</udiDi>
    <basicUdiDi>84354402_MDXRESPB_GAS4V</basicUdiDi>
    <tradeName>VIASURE Group A Streptococcus 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>W0105011103</emdnCode>
    <emdnDescription>STREP. A DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-GAS101E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-05T19:48:53.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440217145</udiDi>
    <basicUdiDi>84354402_MDXRESPB_GAS4V</basicUdiDi>
    <tradeName>VIASURE Group A Streptococcus 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>W0105011103</emdnCode>
    <emdnDescription>STREP. A DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-GAS136E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-05T19:48:51.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440217152</udiDi>
    <basicUdiDi>84354402_MDXRESPB_GAS4V</basicUdiDi>
    <tradeName>VIASURE Group A Streptococcus 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>W0105011103</emdnCode>
    <emdnDescription>STREP. A DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-GAS172E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-05T19:48:51.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440260196</udiDi>
    <basicUdiDi>84354402_MDXRESP_ADUWH</basicUdiDi>
    <tradeName>VIASURE Adenovirus plus Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE Adenovirus plus Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040501</emdnCode>
    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-ADU106LE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-05T19:34:39.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440260189</udiDi>
    <basicUdiDi>84354402_MDXRESP_ADUWH</basicUdiDi>
    <tradeName>VIASURE Adenovirus plus Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE Adenovirus plus Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040501</emdnCode>
    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-ADU101HE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-05T19:20:41.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440260172</udiDi>
    <basicUdiDi>84354402_MDXRESP_ADUWH</basicUdiDi>
    <tradeName>VIASURE Adenovirus plus Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE Adenovirus plus Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040501</emdnCode>
    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-ADU101LE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-05T18:50:07.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440260165</udiDi>
    <basicUdiDi>84354402_MDXRESP_ADUWH</basicUdiDi>
    <tradeName>VIASURE Adenovirus plus Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE Adenovirus plus Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040501</emdnCode>
    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-ADU196T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-05T18:16:32.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440260158</udiDi>
    <basicUdiDi>84354402_MDXRESP_ADUWH</basicUdiDi>
    <tradeName>VIASURE Adenovirus plus Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE Adenovirus plus Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040501</emdnCode>
    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-ADU113H</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-05T17:54:22.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440260141</udiDi>
    <basicUdiDi>84354402_MDXRESP_ADUWH</basicUdiDi>
    <tradeName>VIASURE Adenovirus plus Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE Adenovirus plus Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040501</emdnCode>
    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-ADU113L</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-05T17:30:46.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440260134</udiDi>
    <basicUdiDi>84354402_MDXRESP_ADUWH</basicUdiDi>
    <tradeName>VIASURE Adenovirus plus Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE Adenovirus plus Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040501</emdnCode>
    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-ADU112H</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-05T16:56:48.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440260127</udiDi>
    <basicUdiDi>84354402_MDXRESP_ADUWH</basicUdiDi>
    <tradeName>VIASURE Adenovirus plus Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE Adenovirus plus Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040501</emdnCode>
    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-ADU112L</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-05T16:29:37.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440260110</udiDi>
    <basicUdiDi>84354402_MDXRESP_ADUWH</basicUdiDi>
    <tradeName>VIASURE Adenovirus plus Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE Adenovirus plus Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040501</emdnCode>
    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-ADU106H</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-05T15:49:52.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440260103</udiDi>
    <basicUdiDi>84354402_MDXRESP_ADUWH</basicUdiDi>
    <tradeName>VIASURE Adenovirus plus Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE Adenovirus plus Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040501</emdnCode>
    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-ADU106L</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-05T13:41:57.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440239246</udiDi>
    <basicUdiDi>84354402_MDXRESIST_NCRMS</basicUdiDi>
    <tradeName>VIASURE Neisseria gonorrhoeae ciprofloxacin resistant Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE Neisseria gonorrhoeae ciprofloxacin resistant Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-NCR106L</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-05T13:41:56.226Z</lastUpdated>
  </row>
</eudamedExport>