<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-EBX-039-25DN</udiDi>
    <basicUdiDi>B-EBX-039-25DN</basicUdiDi>
    <tradeName>EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)</tradeName>
    <deviceName>EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011299</emdnCode>
    <emdnDescription>STAPHYLOCOCCI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-039-25</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:47:25.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-039-10049</udiDi>
    <basicUdiDi>B-EBX-039-10049</basicUdiDi>
    <tradeName>EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)</tradeName>
    <deviceName>EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011299</emdnCode>
    <emdnDescription>STAPHYLOCOCCI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-039-100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:47:25.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-039-50DM</udiDi>
    <basicUdiDi>B-EBX-039-50DM</basicUdiDi>
    <tradeName>EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)</tradeName>
    <deviceName>EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011299</emdnCode>
    <emdnDescription>STAPHYLOCOCCI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-039-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:47:25.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>01220000260221</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260221</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>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATMSSA-6MC-IVD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T05:27:01.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>01220000260214</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260214</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>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATMSSE-6MC-IVD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T05:20:55.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>01220000260207</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260207</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>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATMRSA-6MC-IVD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T05:14:45.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>50604724675466</udiDi>
    <basicUdiDi>B-50604724675466</basicUdiDi>
    <tradeName>50604724675466</tradeName>
    <deviceName>Rabbit Coagulase Plasma 30.0 ml</deviceName>
    <manufacturerName>Pro-Lab Diagnostics UK</manufacturerName>
    <manufacturerSrn>GB-MF-000003833</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL.850-30</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:22:47.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>50604724675398</udiDi>
    <basicUdiDi>B-50604724675398</basicUdiDi>
    <tradeName>50604724675398</tradeName>
    <deviceName>Rabbit Coagulase Plasma 20.0 ml</deviceName>
    <manufacturerName>Pro-Lab Diagnostics UK</manufacturerName>
    <manufacturerSrn>GB-MF-000003833</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL.850-20</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:22:45.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>50604724675220</udiDi>
    <basicUdiDi>B-50604724675220</basicUdiDi>
    <tradeName>50604724675220</tradeName>
    <deviceName>Rabbit Coagulase Plasma 10.0 ml</deviceName>
    <manufacturerName>Pro-Lab Diagnostics UK</manufacturerName>
    <manufacturerSrn>GB-MF-000003833</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL.850-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:22:45.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>50604724675152</udiDi>
    <basicUdiDi>B-50604724675152</basicUdiDi>
    <tradeName>50604724675152</tradeName>
    <deviceName>Rabbit Coagulase Plasma 10 x 3.0ml</deviceName>
    <manufacturerName>Pro-Lab Diagnostics UK</manufacturerName>
    <manufacturerSrn>GB-MF-000003833</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL.850-3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:22:39.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940007140</udiDi>
    <basicUdiDi>B-07332940007140</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® MRSA/SA Blood Culture</deviceName>
    <manufacturerName>Cepheid AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXMRSA/SABC-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:56:05.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940002473</udiDi>
    <basicUdiDi>B-07332940002473</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® MRSA /SA SSTI</deviceName>
    <manufacturerName>Cepheid AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXMRSA/SA-SSTI-CE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:55:52.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940001889</udiDi>
    <basicUdiDi>B-07332940001889</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® SA Nasal Complete</deviceName>
    <manufacturerName>Cepheid AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXSACOMP-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:55:39.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382902409151</udiDi>
    <basicUdiDi>038290QUHMNYFQML</basicUdiDi>
    <tradeName>BBL STAPHYLOSLIDE</tradeName>
    <deviceName>BD BBL™ Staphyloslide™ Latex Test Kit</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011299</emdnCode>
    <emdnDescription>STAPHYLOCOCCI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240915</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:42:31.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-30-05-40UPS</udiDi>
    <basicUdiDi>B-CDX-30-05-40UPS</basicUdiDi>
    <tradeName>GenomEra MRSA/SA AC Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Uniogen Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000032341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CDX-30-05-40</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:00:04.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-30-05-40UE</udiDi>
    <basicUdiDi>B-CDX-30-05-40UE</basicUdiDi>
    <tradeName>GenomEra® MRSA/SA AC Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-30-05-40</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:00:04.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-30-05-20UPG</udiDi>
    <basicUdiDi>B-CDX-30-05-20UPG</basicUdiDi>
    <tradeName>GenomEra MRSA/SA AC Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Uniogen Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000032341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CDX-30-05-20</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:59:48.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-30-05-20U8</udiDi>
    <basicUdiDi>B-CDX-30-05-20U8</basicUdiDi>
    <tradeName>GenomEra® MRSA/SA AC Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-30-05-20</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:59:48.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-30-02-20UNF</udiDi>
    <basicUdiDi>B-CDX-30-02-20UNF</basicUdiDi>
    <tradeName>GenomEra MRSA/SA Multi Swab Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Uniogen Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000032341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CDX-30-02-20</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:59:44.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-30-02-20TK</udiDi>
    <basicUdiDi>B-CDX-30-02-20TK</basicUdiDi>
    <tradeName>GenomEra® MRSA/SA Multi Swab Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-30-02-20</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:59:43.250Z</lastUpdated>
  </row>
</eudamedExport>