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<eudamedExport entity="devices">
  <row>
    <udiDi>06976753473252</udiDi>
    <basicUdiDi>B-06976753473252</basicUdiDi>
    <tradeName>Novel Coronavirus (2019-nCOV) Antigen Rapid Test Cassette (swab)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A211301D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:58:50.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753473313</udiDi>
    <basicUdiDi>B-06976753473313</basicUdiDi>
    <tradeName>SARS-Cov-2＆Influenza A＆B Combo Rapid Test Cassette (swab)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A231301D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:58:49.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753473221</udiDi>
    <basicUdiDi>B-06976753473221</basicUdiDi>
    <tradeName>Influenza A&amp;B Rapid Test (Throat swab)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A200101T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:58:35.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753473191</udiDi>
    <basicUdiDi>B-06976753473191</basicUdiDi>
    <tradeName>2019-nCOV IgGIgM Rapid Test Device (whole blood/serum/plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A190501D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:58:31.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753473160</udiDi>
    <basicUdiDi>B-06976753473160</basicUdiDi>
    <tradeName>2-IN-1 COVID-19 Antigen Rapid Test Device (swab)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A181301D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:58:30.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753472989</udiDi>
    <basicUdiDi>B-06976753472989</basicUdiDi>
    <tradeName>2-IN-1 COVID-19 Antigen Rapid Test Device (Nasal&amp;Saliva)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A151601D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:58:22.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202763392</udiDi>
    <basicUdiDi>B-06976202763392</basicUdiDi>
    <tradeName>Zika NS1 Rapid Test</tradeName>
    <deviceName>Zika NS1 Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIZNS1-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:40:04.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202763385</udiDi>
    <basicUdiDi>B-06976202763385</basicUdiDi>
    <tradeName>Zika IgG/IgM Rapid Test</tradeName>
    <deviceName>Zika IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIZGM-422</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:40:01.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202763378</udiDi>
    <basicUdiDi>B-06976202763378</basicUdiDi>
    <tradeName>Zika IgG/IgM/NS1 Combo Rapid Test</tradeName>
    <deviceName>Zika IgG/IgM/NS1 Combo Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIZGMN-432</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:40:00.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202763347</udiDi>
    <basicUdiDi>B-06976202763347</basicUdiDi>
    <tradeName>Enterovirus Rapid Test</tradeName>
    <deviceName>Enterovirus Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040602</emdnCode>
    <emdnDescription>ENTEROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIHEV-422</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:39:53.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202763033</udiDi>
    <basicUdiDi>B-06976202763033</basicUdiDi>
    <tradeName>EV71 IgM Rapid Test</tradeName>
    <deviceName>EV71 IgM Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040602</emdnCode>
    <emdnDescription>ENTEROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIEV71-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:38:49.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762470</udiDi>
    <basicUdiDi>B-06976202762470</basicUdiDi>
    <tradeName>Chikungunya IgG/IgM Rapid Test</tradeName>
    <deviceName>Chikungunya IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040625</emdnCode>
    <emdnDescription>CHIKUNGUNYA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GICHK-422</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:37:12.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762098</udiDi>
    <basicUdiDi>B-06976202762098</basicUdiDi>
    <tradeName>Chikungunya IgM Rapid Test</tradeName>
    <deviceName>Chikungunya IgM Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040625</emdnCode>
    <emdnDescription>CHIKUNGUNYA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GICHKm-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:36:14.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976070371040</udiDi>
    <basicUdiDi>B-06976070371040</basicUdiDi>
    <tradeName>Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Aptamer-Latex method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INSTITUTE OF BASIC MEDICINE AND CANCER（IBMC),CHINESE ACADEMY OF SCIENCES</manufacturerName>
    <manufacturerSrn>CN-MF-000032832</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Type B-2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:28:10.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976070371033</udiDi>
    <basicUdiDi>B-06976070371033</basicUdiDi>
    <tradeName>Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Aptamer-Latex method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INSTITUTE OF BASIC MEDICINE AND CANCER（IBMC),CHINESE ACADEMY OF SCIENCES</manufacturerName>
    <manufacturerSrn>CN-MF-000032832</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Type B-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:51.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976070371026</udiDi>
    <basicUdiDi>B-06976070371026</basicUdiDi>
    <tradeName>Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Aptamer-Latex method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INSTITUTE OF BASIC MEDICINE AND CANCER（IBMC),CHINESE ACADEMY OF SCIENCES</manufacturerName>
    <manufacturerSrn>CN-MF-000032832</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Type A2-2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:50.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976070371019</udiDi>
    <basicUdiDi>B-06976070371019</basicUdiDi>
    <tradeName>Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Aptamer-Latex method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INSTITUTE OF BASIC MEDICINE AND CANCER（IBMC),CHINESE ACADEMY OF SCIENCES</manufacturerName>
    <manufacturerSrn>CN-MF-000032832</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Type A2-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:49.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976070371002</udiDi>
    <basicUdiDi>B-06976070371002</basicUdiDi>
    <tradeName>Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Aptamer-Latex method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INSTITUTE OF BASIC MEDICINE AND CANCER（IBMC),CHINESE ACADEMY OF SCIENCES</manufacturerName>
    <manufacturerSrn>CN-MF-000032832</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Type A1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:48.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975456580274</udiDi>
    <basicUdiDi>B-06975456580274</basicUdiDi>
    <tradeName>BNIBT</tradeName>
    <deviceName>COVID-19 Neutralizing Antibody Rapid Test</deviceName>
    <manufacturerName>Beijing North Institute of Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008259</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RICOV6-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:51:02.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975456580267</udiDi>
    <basicUdiDi>B-06975456580267</basicUdiDi>
    <tradeName>BNIBT</tradeName>
    <deviceName>COVID-19 Neutralizing Antibody Rapid Test</deviceName>
    <manufacturerName>Beijing North Institute of Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008259</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RICOV6</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:51:01.835Z</lastUpdated>
  </row>
</eudamedExport>