<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-81649002RNG01LEKY</udiDi>
    <basicUdiDi>B-81649002RNG01LEKY</basicUdiDi>
    <tradeName>D-81649002RNG01LEKY</tradeName>
    <deviceName>Rapid Varicella-Zoster Virus DNA Test</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>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RNG01-AHG5E/ RNG01-AHG25E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:05:28.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002ANG01EKAN</udiDi>
    <basicUdiDi>B-81649002ANG01EKAN</basicUdiDi>
    <tradeName>D-81649002ANG01EKAN</tradeName>
    <deviceName>Neisseria Gonorrhoeae Detection Kit (Fluorescence PCR)</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>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ANG01-AHG48E; ANG01-AHG96E; ANG01D-AHG48E; ANG01D-AHG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:04:29.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002ANG01DBACU</udiDi>
    <basicUdiDi>B-81649002ANG01DBACU</basicUdiDi>
    <tradeName>D-81649002ANG01DBACU</tradeName>
    <deviceName>Neisseria Gonorrhoeae Fluorescence PCR Kit (Lyophilized)</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>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ANG01D-AHG48E; ANG01D-AHG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:04:28.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548259752</udiDi>
    <basicUdiDi>B-08683548259752</basicUdiDi>
    <tradeName>LyoSens CT/NG/MG Genotyping qPCR Kit</tradeName>
    <deviceName>CT/NG/MG 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>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO54</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:21:06.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301927</udiDi>
    <basicUdiDi>B-08595696301927</basicUdiDi>
    <tradeName>GeneProof Neisseria gonorrhoeae MC PCR Kit</tradeName>
    <deviceName>GeneProof Neisseria gonorrhoeae MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NG/MC/190</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:25.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301903</udiDi>
    <basicUdiDi>B-08595696301903</basicUdiDi>
    <tradeName>GeneProof Neisseria gonorrhoeae MC PCR Kit</tradeName>
    <deviceName>GeneProof Neisseria gonorrhoeae MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NG/MC/038</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:23.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975400320147</udiDi>
    <basicUdiDi>B-06975400320147</basicUdiDi>
    <tradeName>VIUICK</tradeName>
    <deviceName>Diagnostic Kit for Neisseria gonorrhoeae DNA (Real-Time PCR Method)</deviceName>
    <manufacturerName>Guangzhou Viuick Biotechnology Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000017369</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:31:05.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974912093730</udiDi>
    <basicUdiDi>B-06974912093730</basicUdiDi>
    <tradeName>Neisseria gonorrhoeae Real-time PCR Kit</tradeName>
    <deviceName>Neisseria gonorrhoeae Real-time PCR Kit</deviceName>
    <manufacturerName>Nexlab Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047094</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITSZ090001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:02:05.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974858560020</udiDi>
    <basicUdiDi>B-06974858560020</basicUdiDi>
    <tradeName>06974858560020</tradeName>
    <deviceName>Neisseria Gonorrhoeae (NG) Nucleic Acid Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>Suzhou TianLong Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001080</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P180H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:57:56.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974858560013</udiDi>
    <basicUdiDi>B-06974858560013</basicUdiDi>
    <tradeName>06974858560013</tradeName>
    <deviceName>Neisseria Gonorrhoeae (NG) Nucleic Acid Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>Suzhou TianLong Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001080</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P104H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:57:55.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323012962</udiDi>
    <basicUdiDi>B-06974323012962</basicUdiDi>
    <tradeName>06974323012962</tradeName>
    <deviceName>PCR-based Neisseria Gonorrhoeae Test Kit (Fluorometric PCR)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:52:19.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323012955</udiDi>
    <basicUdiDi>B-06974323012955</basicUdiDi>
    <tradeName>06974323012955</tradeName>
    <deviceName>PCR-based Neisseria Gonorrhoeae Test Kit (Fluorometric PCR)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:52:15.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972221451180</udiDi>
    <basicUdiDi>B-06972221451180</basicUdiDi>
    <tradeName>06972221451180</tradeName>
    <deviceName>Neisseria Gonorrhoea (NG) Nucleic Acid Detection Kit (Fluorescent PCR Method)</deviceName>
    <manufacturerName>CapitalBio Technology (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027694</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:44:40.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100835</udiDi>
    <basicUdiDi>B-04251557100835</basicUdiDi>
    <tradeName>04251557100835</tradeName>
    <deviceName>Neisseria gonorrhoeae PCR kit (Form T)</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>84-04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:33.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100828</udiDi>
    <basicUdiDi>B-04251557100828</basicUdiDi>
    <tradeName>04251557100828</tradeName>
    <deviceName>Neisseria gonorrhoeae PCR kit (Form S)</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>84-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:27.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251557100811</udiDi>
    <basicUdiDi>B-04251557100811</basicUdiDi>
    <tradeName>04251557100811</tradeName>
    <deviceName>Neisseria gonorrhoeae PCR kit (Form F)</deviceName>
    <manufacturerName>Astra Biotech GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026439</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>84-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:46:26.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>09352224000238</udiDi>
    <basicUdiDi>9352224020110WC</basicUdiDi>
    <tradeName>ResistancePlus GC(610)</tradeName>
    <deviceName>ResistancePlus GC</deviceName>
    <manufacturerName>SpeeDx Pty. Ltd.</manufacturerName>
    <manufacturerSrn>AU-MF-000016649</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</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>2011025</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:07:16.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045505421</udiDi>
    <basicUdiDi>54200455DIAGAPTGCQL</basicUdiDi>
    <tradeName>Aptima Neisseria gonorrhoeae</tradeName>
    <deviceName>Aptima Neisseria gonorrhoeae Assay</deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</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>302927</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:05:43.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>01220000260030</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260030</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>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATNG-6MC-IVD</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:22:45.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304027</udiDi>
    <basicUdiDi>859569630025QH</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Neisseria gonorrhoeae PCR Kit</tradeName>
    <deviceName>GeneProof Neisseria gonorrhoeae PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</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>A58124</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:59:36.561Z</lastUpdated>
  </row>
</eudamedExport>