<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03573026550455</udiDi>
    <basicUdiDi>357302BUDI000734TW</basicUdiDi>
    <tradeName>ETEST® Metronidazole (MZ)</tradeName>
    <deviceName>ETEST® Metronidazole (MZ)</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080501</emdnCode>
    <emdnDescription>MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8309002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:49.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026549992</udiDi>
    <basicUdiDi>357302BUDI000621TG</basicUdiDi>
    <tradeName>ETEST® Cefepime (PM)</tradeName>
    <deviceName>ETEST® Cefepime (PM)</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080501</emdnCode>
    <emdnDescription>MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8308956</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:49.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-211045-20-061CQ</udiDi>
    <basicUdiDi>B-211045-20-061CQ</basicUdiDi>
    <tradeName>KPC/IMP/NDM/VIM/OXA-48  Combo Test Kit (LFIA)</tradeName>
    <deviceName>KPC/IMP/NDM/VIM/OXA-48  Combo Test Kit (LFIA)</deviceName>
    <manufacturerName>Jiangsu Medomics Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030226</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080506</emdnCode>
    <emdnDescription>TARGETED RESISTANCE TESTS - CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211045-20-061</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T22:49:45.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-211045-01-061C9</udiDi>
    <basicUdiDi>B-211045-01-061C9</basicUdiDi>
    <tradeName>KPC/IMP/NDM/VIM/OXA-48  Combo Test Kit (LFIA)</tradeName>
    <deviceName>KPC/IMP/NDM/VIM/OXA-48  Combo Test Kit (LFIA)</deviceName>
    <manufacturerName>Jiangsu Medomics Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030226</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080506</emdnCode>
    <emdnDescription>TARGETED RESISTANCE TESTS - CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211045-01-061</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T22:49:45.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057920720862</udiDi>
    <basicUdiDi>8057920MICANTDISCHILL</basicUdiDi>
    <tradeName>Optochin disc</tradeName>
    <deviceName>Dischi Impregnati</deviceName>
    <manufacturerName>Microbiol S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000052547</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080502</emdnCode>
    <emdnDescription>IMPREGNATED DISKS, MULTI-DISKS &amp; TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MICOP5-50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:09:06.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384546381</udiDi>
    <basicUdiDi>5032384SEMSE7RP</basicUdiDi>
    <tradeName>05032384546381</tradeName>
    <deviceName>Sensititre™ SEMSE7</deviceName>
    <manufacturerName>Trek Diagnostic Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016922</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080599</emdnCode>
    <emdnDescription>MANUAL SUSCEPTIBILITY TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SENSITITRE SUSCEPTIBILITY NON-FASTIDIOUS GRAM POSITIVE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:45:08.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HG06HS</udiDi>
    <basicUdiDi>B-HG06HS</basicUdiDi>
    <tradeName>Cowingene MRSA/SA Detection Kit</tradeName>
    <deviceName>Cowingene MRSA/SA Detection Kit</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080504</emdnCode>
    <emdnDescription>TARGETED RESISTANCE TESTS - MRSA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HG06021X, HG06022X, HG06023W</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:54:43.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCRE-T1402aHGFX</udiDi>
    <basicUdiDi>B-GCCRE-T1402aHGFX</basicUdiDi>
    <tradeName>CARBA 5 In 1 Rapid Test Cassette</tradeName>
    <deviceName>CARBA 5 In 1 Rapid Test Cassette</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080506</emdnCode>
    <emdnDescription>TARGETED RESISTANCE TESTS - CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCRE-T1402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:29.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057920720879</udiDi>
    <basicUdiDi>8057920MICANTDISCHILL</basicUdiDi>
    <tradeName>Bacitracin disc</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbiol S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000052547</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080502</emdnCode>
    <emdnDescription>IMPREGNATED DISKS, MULTI-DISKS &amp; TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MICB04-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:59:57.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057920720886</udiDi>
    <basicUdiDi>8057920MICANTDISCHILL</basicUdiDi>
    <tradeName>Metronidazolo disc</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbiol S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000052547</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080502</emdnCode>
    <emdnDescription>IMPREGNATED DISKS, MULTI-DISKS &amp; TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MICMET50-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:59:53.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057920720893</udiDi>
    <basicUdiDi>8057920MICANTDISCHILL</basicUdiDi>
    <tradeName>ESBL DISC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbiol S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000052547</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080502</emdnCode>
    <emdnDescription>IMPREGNATED DISKS, MULTI-DISKS &amp; TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MICESBL-1K</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:59:52.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057920720909</udiDi>
    <basicUdiDi>8057920MICANTDISCHILL</basicUdiDi>
    <tradeName>Oxidase Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbiol S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000052547</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080502</emdnCode>
    <emdnDescription>IMPREGNATED DISKS, MULTI-DISKS &amp; TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>O.80260</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:59:52.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698601443</udiDi>
    <basicUdiDi>B-16972698601443</basicUdiDi>
    <tradeName>Carbapenemase Rapid Test</tradeName>
    <deviceName>Carbapenemase 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>W0104080506</emdnCode>
    <emdnDescription>TARGETED RESISTANCE TESTS - CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P261102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:26.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698601238</udiDi>
    <basicUdiDi>B-16972698601238</basicUdiDi>
    <tradeName>MCR-1 Enzyme Rapid Test</tradeName>
    <deviceName>MCR-1 Enzyme 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>W0104080590</emdnCode>
    <emdnDescription>TARGETED RESISTANCE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P261105</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:05.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698601221</udiDi>
    <basicUdiDi>B-16972698601221</basicUdiDi>
    <tradeName>CTX-M β-lactamases Rapid Test</tradeName>
    <deviceName>CTX-M β-lactamases 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>W0104080505</emdnCode>
    <emdnDescription>TARGETED RESISTANCE TESTS - ESBL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P261104</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:01.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698601214</udiDi>
    <basicUdiDi>B-16972698601214</basicUdiDi>
    <tradeName>OXA-23 Carbapenemase Rapid Test</tradeName>
    <deviceName>OXA-23 Carbapenemase 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>W0104080506</emdnCode>
    <emdnDescription>TARGETED RESISTANCE TESTS - CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P261103</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:01.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420071901006</udiDi>
    <basicUdiDi>B-15420071901006</basicUdiDi>
    <tradeName>RESIST-1 MCR Multi Mobilised colistin resistance rapid test</tradeName>
    <deviceName>RESIST-1 MCR Multi Mobilised colistin resistance rapid test</deviceName>
    <manufacturerName>Coris BioConcept</manufacturerName>
    <manufacturerSrn>BE-MF-000024520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080590</emdnCode>
    <emdnDescription>TARGETED RESISTANCE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-13R15</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:44:14.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420071900993</udiDi>
    <basicUdiDi>B-15420071900993</basicUdiDi>
    <tradeName>RESIST-1 MCR Multi Mobilised colistin resistance rapid test</tradeName>
    <deviceName>RESIST-1 MCR Multi Mobilised colistin resistance rapid test</deviceName>
    <manufacturerName>Coris BioConcept</manufacturerName>
    <manufacturerSrn>BE-MF-000024520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080590</emdnCode>
    <emdnDescription>TARGETED RESISTANCE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-15R15</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:44:13.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763389</udiDi>
    <basicUdiDi>B-15065023763389</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>Carbapenem Resistant Enterobacteriaceae assay (LFA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080506</emdnCode>
    <emdnDescription>TARGETED RESISTANCE TESTS - CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV10039</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:35:08.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698874205137</udiDi>
    <basicUdiDi>B-08698874205137</basicUdiDi>
    <tradeName>CEFTOBIPROLE 30 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</tradeName>
    <deviceName>CEFTOBIPROLE 30 µg ANTIMICROBIAL SUSCEPTIBILITY TEST DISCS</deviceName>
    <manufacturerName>Bioanalyse Tıbbi Malzemeler Sanayi ve Ticaret Anonim Şirketi</manufacturerName>
    <manufacturerSrn>TR-MF-000046898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080503</emdnCode>
    <emdnDescription>MANUAL ANTIMICROBIAL SUCEPTIBILITY TESTING (AST)-  STRIPS / CASSETTES/GALLERIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASD09631</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:55:12.189Z</lastUpdated>
  </row>
</eudamedExport>