<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-697994388Fa009WK8D</udiDi>
    <basicUdiDi>B-697994388Fa009WK8D</basicUdiDi>
    <tradeName>D-697994388Fa009WK8D</tradeName>
    <deviceName>Monkeypox 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>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Fa009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:19:11.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697603130AMPV01EMWG</udiDi>
    <basicUdiDi>B-697603130AMPV01EMWG</basicUdiDi>
    <tradeName>D-697603130AMPV01EMWG</tradeName>
    <deviceName>Monkeypox 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>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMPV01，AMPV01D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:55.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69509960AMPV01UYBQ</udiDi>
    <basicUdiDi>B-69509960AMPV01UYBQ</basicUdiDi>
    <tradeName>D-69509960AMPV01UYBQ</tradeName>
    <deviceName>Monkeypox 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>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMPV01-AOG48E; AMPV01-AOG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:52:56.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST08NC</udiDi>
    <basicUdiDi>B-ST08NC</basicUdiDi>
    <tradeName>Cowingene Monkeypox Virus Typing Detection Kit</tradeName>
    <deviceName>Cowingene Monkeypox Virus Typing 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>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST08011X, ST08012X, ST08013W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:42:53.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST07NA</udiDi>
    <basicUdiDi>B-ST07NA</basicUdiDi>
    <tradeName>Cowingene Monkeypox Virus Detection Kit</tradeName>
    <deviceName>Cowingene Monkeypox 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>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST07011X, ST07012X, ST07013W</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:42:20.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002AMPV01HGSL</udiDi>
    <basicUdiDi>B-81649002AMPV01HGSL</basicUdiDi>
    <tradeName>D-81649002AMPV01HGSL</tradeName>
    <deviceName>Monkeypox 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>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMPV01-AHG48E; AMPV01-AHG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:04:22.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002AMPV01DK32Z</udiDi>
    <basicUdiDi>B-81649002AMPV01DK32Z</basicUdiDi>
    <tradeName>D-81649002AMPV01DK32Z</tradeName>
    <deviceName>Monkeypox 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>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMPV01D-AHG48E; AMPV01D-AHG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:04:20.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387214254</udiDi>
    <basicUdiDi>B-08684387214254</basicUdiDi>
    <tradeName>RevoDx Monkeypox qPCR Kit</tradeName>
    <deviceName>RevoDx Monkeypox 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>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202224-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:01:00.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974969983039</udiDi>
    <basicUdiDi>B-06974969983039</basicUdiDi>
    <tradeName>Monkeypox Virus Real Time PCR Kit</tradeName>
    <deviceName>Monkeypox Virus Real Time PCR Kit</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 rxns/kit（DR1160-1）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:17:49.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974767391913</udiDi>
    <basicUdiDi>B-06974767391913</basicUdiDi>
    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE Monkeypox Virus Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6018022507-CE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:41:56.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974767391739</udiDi>
    <basicUdiDi>B-06974767391739</basicUdiDi>
    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE Monkeypox Virus Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6018022502-CE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:41:52.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323012047</udiDi>
    <basicUdiDi>B-06974323012047</basicUdiDi>
    <tradeName>06974323012047</tradeName>
    <deviceName>Real-time PCR Detection Kit for Monkeypox Virus</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>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D2361YH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:49:19.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323012030</udiDi>
    <basicUdiDi>B-06974323012030</basicUdiDi>
    <tradeName>06974323012030</tradeName>
    <deviceName>Real-time PCR Detection Kit for Monkeypox Virus</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>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D2361YH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:49:18.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970895479509</udiDi>
    <basicUdiDi>B-06970895479509</basicUdiDi>
    <tradeName>06970895479509</tradeName>
    <deviceName>Monkeypox Virus Nucleic Acid Detection Kit (Fluorescent Probe-based Real-time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R60101T2050</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:00:30.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970514080949</udiDi>
    <basicUdiDi>B-06970514080949</basicUdiDi>
    <tradeName>06970514080949</tradeName>
    <deviceName>Monkeypox Virus Molecular Detection Kit (Real-time PCR)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MXVPCR-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:24.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970514080932</udiDi>
    <basicUdiDi>B-06970514080932</basicUdiDi>
    <tradeName>06970514080932</tradeName>
    <deviceName>Monkeypox Virus Molecular Detection Kit (Real-time PCR)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MXVPCR-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:21.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020115414</udiDi>
    <basicUdiDi>B-06936020115414</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD76-02-20t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:09:49.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020115407</udiDi>
    <basicUdiDi>B-06936020115407</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD76-02-5t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:09:48.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020115391</udiDi>
    <basicUdiDi>B-06936020115391</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPV-02-01t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:09:47.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020115384</udiDi>
    <basicUdiDi>B-06936020115384</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPV-02-20t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:09:46.111Z</lastUpdated>
  </row>
</eudamedExport>