<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-JB10130NW-25TMH</udiDi>
    <basicUdiDi>B-JB10130NW-25TMH</basicUdiDi>
    <tradeName>Clostridioides difficile Real Time PCR Ki</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JB10130NW-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:22:14.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCD-602aRS</udiDi>
    <basicUdiDi>B-GCCD-602aRS</basicUdiDi>
    <tradeName>Clostridium difficile GDH &amp; Toxin A/B Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Clostridium difficile GDH &amp; Toxin A/B Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011803</emdnCode>
    <emdnDescription>C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCD-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:17.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCD(ToxinAB)-602aZC</udiDi>
    <basicUdiDi>B-GCCD(ToxinAB)-602aZC</basicUdiDi>
    <tradeName>Clostridium difficile Toxin A&amp;B Rapid Test Casette (Feces)</tradeName>
    <deviceName>Clostridium difficile Toxin A&amp;B Rapid Test Casette (Feces)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011802</emdnCode>
    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCD(Toxin A/B)-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:12.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCD(GDH)-602aH3</udiDi>
    <basicUdiDi>B-GCCD(GDH)-602aH3</basicUdiDi>
    <tradeName>Clostridium difficile Antigen GDH Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Clostridium difficile Antigen GDH Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011801</emdnCode>
    <emdnDescription>C.DIFFICILE GDH DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCD(GDH)-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:05.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-40-02-40UPG</udiDi>
    <basicUdiDi>B-CDX-40-02-40UPG</basicUdiDi>
    <tradeName>GenomEra C. difficile 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>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CDX-40-02-40</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:00:12.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-40-02-40UC</udiDi>
    <basicUdiDi>B-CDX-40-02-40UC</basicUdiDi>
    <tradeName>GenomEra® C. difficile 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>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-40-02-40</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:00:12.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-40-01-40UP5</udiDi>
    <basicUdiDi>B-CDX-40-01-40UP5</basicUdiDi>
    <tradeName>GenomEra® C. difficile 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>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CDX-40-01-40</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:00:11.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-40-01-40U5</udiDi>
    <basicUdiDi>B-CDX-40-01-40U5</basicUdiDi>
    <tradeName>GenomEra® C. difficile 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>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-40-01-40</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:00:10.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-40-01-20UNT</udiDi>
    <basicUdiDi>B-CDX-40-01-20UNT</basicUdiDi>
    <tradeName>GenomEra C. difficile 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>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CDX-40-01-20</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:00:06.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-40-01-20TX</udiDi>
    <basicUdiDi>B-CDX-40-01-20TX</basicUdiDi>
    <tradeName>GenomEra® C. difficile 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>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-40-01-20</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:00:05.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2R04ES</udiDi>
    <basicUdiDi>B-2R04ES</basicUdiDi>
    <tradeName>mariPOC® Clostridium difficile Toxin A/B test reagent</tradeName>
    <deviceName>mariPOC® Clostridium difficile Toxin A/B test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011802</emdnCode>
    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2R04</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:58:35.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2R03EQ</udiDi>
    <basicUdiDi>B-2R03EQ</basicUdiDi>
    <tradeName>mariPOC® Clostridium difficile GDH test reagent</tradeName>
    <deviceName>mariPOC® Clostridium difficile GDH test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011801</emdnCode>
    <emdnDescription>C.DIFFICILE GDH DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2R03</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:58:34.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2037MGY</udiDi>
    <basicUdiDi>B-2037MGY</basicUdiDi>
    <tradeName>mariPOC® CDI test plate</tradeName>
    <deviceName>mariPOC® CDI test plate</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011803</emdnCode>
    <emdnDescription>C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:28:11.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698604222</udiDi>
    <basicUdiDi>B-16972698604222</basicUdiDi>
    <tradeName>C. difficile GDH &amp; Toxin A+B Combo Rapid Test</tradeName>
    <deviceName>C. difficile GDH &amp; Toxin A+B Combo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011803</emdnCode>
    <emdnDescription>C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P221115</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:53:05.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698601399</udiDi>
    <basicUdiDi>B-16972698601399</basicUdiDi>
    <tradeName>C. difficile GDH &amp; Toxin A/B Combo Rapid Test</tradeName>
    <deviceName>C. difficile GDH &amp; Toxin A/B Combo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011803</emdnCode>
    <emdnDescription>C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P221109</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:20.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013953046</udiDi>
    <basicUdiDi>B-08885013953046</basicUdiDi>
    <tradeName>Sentosa SA C. diff PCR Test v2.0 (4x24)</tradeName>
    <deviceName>Sentosa SA C. diff PCR Test v2.0 (4x24)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000249</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:16:47.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387211895</udiDi>
    <basicUdiDi>B-08684387211895</basicUdiDi>
    <tradeName>RevoDx Clostridium difficile qPCR Kit</tradeName>
    <deviceName>RevoDx Clostridium difficile qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011802</emdnCode>
    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202409-500</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:51:52.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387211888</udiDi>
    <basicUdiDi>B-08684387211888</basicUdiDi>
    <tradeName>RevoDx Clostridium difficile qPCR Kit</tradeName>
    <deviceName>RevoDx Clostridium difficile qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011802</emdnCode>
    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202409-100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:51:51.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387211871</udiDi>
    <basicUdiDi>B-08684387211871</basicUdiDi>
    <tradeName>RevoDx Clostridium difficile qPCR Kit</tradeName>
    <deviceName>RevoDx Clostridium difficile qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011802</emdnCode>
    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202409-50</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:51:50.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548259448</udiDi>
    <basicUdiDi>B-08683548259448</basicUdiDi>
    <tradeName>LyoSens Clostridium diﬀicile toxin A/B Genotyping qPCR Kit</tradeName>
    <deviceName>Clostridium diﬀicile toxin A/B Genotyping qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:20:53.299Z</lastUpdated>
  </row>
</eudamedExport>