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<eudamedExport entity="devices">
  <row>
    <udiDi>D-697994388Nc0472499</udiDi>
    <basicUdiDi>B-697994388Nc0472499</basicUdiDi>
    <tradeName>D-697994388Nc0472499</tradeName>
    <deviceName>Dengue Virus Genotyping Nucleic Acid Detection Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Nc047</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:28:14.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Fa047WT9H</udiDi>
    <basicUdiDi>B-697994388Fa047WT9H</basicUdiDi>
    <tradeName>D-697994388Fa047WT9H</tradeName>
    <deviceName>Dengue Virus Genotyping Nucleic Acid Detection Kit (Fluorescence)</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Fa047</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:23:05.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Fa008WH82</udiDi>
    <basicUdiDi>B-697994388Fa008WH82</basicUdiDi>
    <tradeName>D-697994388Fa008WH82</tradeName>
    <deviceName>Dengue Virus Nucleic Acid Detection Kit (Fluorescence)</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Fa008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:19:14.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130CMTBMDR01A3QKW</udiDi>
    <basicUdiDi>B-697603130CMTBMDR01A3QKW</basicUdiDi>
    <tradeName>D-697603130CMTBMDR01A3QKW</tradeName>
    <deviceName>GeneStream MTB MDR Assay</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>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMTBMDR01A-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:18:10.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130CDGV01ADQY7</udiDi>
    <basicUdiDi>B-697603130CDGV01ADQY7</basicUdiDi>
    <tradeName>D-697603130CDGV01ADQY7</tradeName>
    <deviceName>GeneStream Dengue Virus Typing Assay</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>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDGV01A-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:18:00.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130A0211EYRJ3C</udiDi>
    <basicUdiDi>B-697603130A0211EYRJ3C</basicUdiDi>
    <tradeName>D-697603130A0211EYRJ3C</tradeName>
    <deviceName>Dengue Virus 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>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101A0211EY，101A0211ED</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:45.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69509960ADV01QJRZ</udiDi>
    <basicUdiDi>B-69509960ADV01QJRZ</basicUdiDi>
    <tradeName>D-69509960ADV01QJRZ</tradeName>
    <deviceName>Dengue Virus 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>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADV01-AOG48E;,ADV01-AOG96E,ADV01D-AOG48E,ADV01D-AOG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:52:17.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JC30203NW-50TR5</udiDi>
    <basicUdiDi>B-JC30203NW-50TR5</basicUdiDi>
    <tradeName>Dengue Virus Type 3 &amp; Type 4 Real Time PCR Kit</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>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JC30203NW-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:23:46.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JC30203NW-25TR5</udiDi>
    <basicUdiDi>B-JC30203NW-25TR5</basicUdiDi>
    <tradeName>Dengue Virus Type 3 &amp; Type 4 Real Time PCR Kit</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>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JC30203NW-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:23:45.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JC30202NW-50TQL</udiDi>
    <basicUdiDi>B-JC30202NW-50TQL</basicUdiDi>
    <tradeName>Dengue Virus Type 1 &amp; Type 2 Real Time PCR Kit</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>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JC30202NW-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:23:44.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JC30202NW-25TQL</udiDi>
    <basicUdiDi>B-JC30202NW-25TQL</basicUdiDi>
    <tradeName>Dengue Virus Type 1 &amp; Type 2 Real Time PCR Kit</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>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JC30202NW-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:23:44.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JC30101NW-48TPX</udiDi>
    <basicUdiDi>B-JC30101NW-48TPX</basicUdiDi>
    <tradeName>Dengue Virus Real Time PCR Kit</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>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JC30101NW-48T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:23:38.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M705021EW</udiDi>
    <basicUdiDi>B-G2M705021EW</basicUdiDi>
    <tradeName>DENGUE-Q Real Time PCR Kit</tradeName>
    <deviceName>DENGUE-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>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M705021, G2M705021R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:43:32.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FE08H6</udiDi>
    <basicUdiDi>B-FE08H6</basicUdiDi>
    <tradeName>Cowingene Dengue Virus Detection Kit</tradeName>
    <deviceName>Cowingene Dengue Virus 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>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FE08021X, FE08021X, FE08023W</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:23:15.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FE02GS</udiDi>
    <basicUdiDi>B-FE02GS</basicUdiDi>
    <tradeName>Cowingene Dengue Virus I/II/III/IV Detection Kit</tradeName>
    <deviceName>Cowingene Dengue Virus I/II/III/IV 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>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FE02021X, FE02022X, FE02023W</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:23:11.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-018QK</udiDi>
    <basicUdiDi>B-EBX-018QK</basicUdiDi>
    <tradeName>EurobioPlex Dengue 1234</tradeName>
    <deviceName>EurobioPlex Dengue 1234</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-018</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:25.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-018-48D5</udiDi>
    <basicUdiDi>B-EBX-018-48D5</basicUdiDi>
    <tradeName>EurobioPlex Dengue 1234</tradeName>
    <deviceName>EurobioPlex Dengue 1234</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-018-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:24.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-018-24CP</udiDi>
    <basicUdiDi>B-EBX-018-24CP</basicUdiDi>
    <tradeName>EurobioPlex Dengue 1234</tradeName>
    <deviceName>EurobioPlex Dengue 1234</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-018-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:23.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002ADV01EQC5</udiDi>
    <basicUdiDi>B-81649002ADV01EQC5</basicUdiDi>
    <tradeName>D-81649002ADV01EQC5</tradeName>
    <deviceName>Dengue Virus 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>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADV01-AHG48E; ADV01-AHG96E; ADV01D-AHG48E; ADV01D-AHG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:59:31.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002ADV01DB5CX</udiDi>
    <basicUdiDi>B-81649002ADV01DB5CX</basicUdiDi>
    <tradeName>D-81649002ADV01DB5CX</tradeName>
    <deviceName>Dengue Virus 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>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADV01D-AHG48E; ADV01D-AHG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:59:30.276Z</lastUpdated>
  </row>
</eudamedExport>