<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-697603130A0217EYSG5B</udiDi>
    <basicUdiDi>B-697603130A0217EYSG5B</basicUdiDi>
    <tradeName>D-697603130A0217EYSG5B</tradeName>
    <deviceName>Neisseria Gonorrhoeae Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</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>101A0217EY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:50.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840311174</udiDi>
    <basicUdiDi>B-69743840311174</basicUdiDi>
    <tradeName>Gonorrhea Antigen Rapid Test</tradeName>
    <deviceName>Gonorrhea Antigen Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010201</emdnCode>
    <emdnDescription>GONOCOCCAL ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3024101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:36.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69509960ANG01QDQJ</udiDi>
    <basicUdiDi>B-69509960ANG01QDQJ</basicUdiDi>
    <tradeName>D-69509960ANG01QDQJ</tradeName>
    <deviceName>Neisseria Gonorrhoeae Detection Kit (Fluorescence PCR)</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>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ANG01-AOG48E;,ANG01-AOG96E,ANG01D-AOG48E,  ANG01D-AOG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:53:01.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974785750587</udiDi>
    <basicUdiDi>B-06974785750587</basicUdiDi>
    <tradeName>Gonorrhea Rapid Test (Swab)</tradeName>
    <deviceName>Gonorrhea Rapid Test (Swab)</deviceName>
    <manufacturerName>Anhui Formaster Biosci Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002305</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010201</emdnCode>
    <emdnDescription>GONOCOCCAL ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WGO-1013</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:53.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IGO-R502EQ</udiDi>
    <basicUdiDi>B-IGO-R502EQ</basicUdiDi>
    <tradeName>Gonorrhea Rapid Test Cassette</tradeName>
    <deviceName>Gonorrhea Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010201</emdnCode>
    <emdnDescription>GONOCOCCAL ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGO-R502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:09:28.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD158XV</udiDi>
    <basicUdiDi>B-GKPD158XV</basicUdiDi>
    <tradeName>Neisseria gonorrhoeae Ag Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>Neisseria gonorrhoeae Ag Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010202</emdnCode>
    <emdnDescription>GONOCOCCAL ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD158</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:48.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCGON-502bHG3H</udiDi>
    <basicUdiDi>B-GCGON-502bHG3H</basicUdiDi>
    <tradeName>Gonorrhea Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Gonorrhea Rapid Test Cassette (Swab)</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>W0105010201</emdnCode>
    <emdnDescription>GONOCOCCAL ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCGON-502b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:27:20.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCGON-502b3G</udiDi>
    <basicUdiDi>B-GCGON-502b3G</basicUdiDi>
    <tradeName>Gonorrhea Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Gonorrhea Rapid Test Cassette (Swab)</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>W0105010201</emdnCode>
    <emdnDescription>GONOCOCCAL ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCGON-502b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:27:18.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M706421FR</udiDi>
    <basicUdiDi>B-G2M706421FR</basicUdiDi>
    <tradeName>N. Gonorrhoeae-Q Real-Time PCR Kit</tradeName>
    <deviceName>N. Gonorrhoeae-Q Real-Time PCR Kit</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M706421, G2M706421R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:44:10.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCGON-502aHG27</udiDi>
    <basicUdiDi>B-FCGON-502aHG27</basicUdiDi>
    <tradeName>Healgen® Gonorrhoea Fluorescent Rapid Test</tradeName>
    <deviceName></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>W0105010201</emdnCode>
    <emdnDescription>GONOCOCCAL ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCGON-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:18:37.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCGON-502a2H</udiDi>
    <basicUdiDi>B-FCGON-502a2H</basicUdiDi>
    <tradeName>Healgen® Gonorrhoea Fluorescent Rapid Test</tradeName>
    <deviceName>Healgen® Gonorrhoea Fluorescent Rapid Test</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>W0105010201</emdnCode>
    <emdnDescription>GONOCOCCAL ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCGON-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:18:36.329Z</lastUpdated>
  </row>
  <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>08684998274852</udiDi>
    <basicUdiDi>B-08684998274852</basicUdiDi>
    <tradeName>LyoSens  Neisseria gonorrhoease qPCR Kit</tradeName>
    <deviceName>Neisseria gonorrhoeae 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>LYO47</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:21:34.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595036877</udiDi>
    <basicUdiDi>B-08684595036877</basicUdiDi>
    <tradeName>RapidFor™ Neisseria Gonorrhoeae Rapid Test Kit (FIA)</tradeName>
    <deviceName>Neisseria Gonorrhoeae Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010201</emdnCode>
    <emdnDescription>GONOCOCCAL ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO104SD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:16:57.511Z</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>08683548257734</udiDi>
    <basicUdiDi>B-08683548257734</basicUdiDi>
    <tradeName>ChainFor Neisseria Gonorrhoeae Detection qPCR kit</tradeName>
    <deviceName>Neisseria Gonorrhoeae Detection 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>CFP75</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:16:52.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683347941452</udiDi>
    <basicUdiDi>B-08683347941452</basicUdiDi>
    <tradeName>RapidFor™ Neisseria Gonorrhoeae Rapid Test Kit</tradeName>
    <deviceName>Neisseria Gonorrhoeae Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010201</emdnCode>
    <emdnDescription>GONOCOCCAL ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD39</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:04:40.183Z</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>
</eudamedExport>