<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-697424646BRU001KY3J</udiDi>
    <basicUdiDi>B-697424646BRU001KY3J</basicUdiDi>
    <tradeName>Brucella IgG/IgM Rapid Test(WB/S/P)</tradeName>
    <deviceName>Brucella IgG/IgM Rapid Test(WB/S/P)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Bru-4022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:03:02.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646BRU000KW39</udiDi>
    <basicUdiDi>B-697424646BRU000KW39</basicUdiDi>
    <tradeName>Brucella IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Brucella IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BRU-4022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:03:01.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ADV001EYT9</udiDi>
    <basicUdiDi>B-697424646ADV001EYT9</basicUdiDi>
    <tradeName>Adenovirus Antigen Rapid Test (Feces)</tradeName>
    <deviceName>Adenovirus Antigen Rapid Test (Feces)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADV-5011/ADV-5012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:02:31.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ADV000EWSY</udiDi>
    <basicUdiDi>B-697424646ADV000EWSY</basicUdiDi>
    <tradeName>Adenovirus Rapid Test (Feces)</tradeName>
    <deviceName>Adenovirus Rapid Test (Feces)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADV-5011/ADV-5012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:02:31.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712042779P</udiDi>
    <basicUdiDi>B-69717712042779P</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Influenza A+B/ COVID-19/ RSV/ADV/HMPV/HPIV Antigen  Rapid Test</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCRAHP-S27</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:00:43.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712009349C</udiDi>
    <basicUdiDi>B-69717712009349C</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Dengue Rapid test</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEG-W21（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:57:14.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712009279F</udiDi>
    <basicUdiDi>B-69717712009279F</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Syphilis Rapid test</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYP-W21（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:57:11.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712009108W</udiDi>
    <basicUdiDi>B-69717712009108W</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Strep A Rapid Test</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STP-S21（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:57:11.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712009038Z</udiDi>
    <basicUdiDi>B-69717712009038Z</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Malaria Rapid Test</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-W21- FV（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:57:08.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712008979X</udiDi>
    <basicUdiDi>B-69717712008979X</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>H.Pylori Rapid Test</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-F21（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:57:05.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69509960APA01PVQB</udiDi>
    <basicUdiDi>B-69509960APA01PVQB</basicUdiDi>
    <tradeName>D-69509960APA01PVQB</tradeName>
    <deviceName>Influenza A/ B and Respiratory Syncytial 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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFR01-AOG48E; AFR01-AOG96E; AFR01D-AOG48E; AFR01D-AOG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:53:01.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69509960AFAB01L6PY</udiDi>
    <basicUdiDi>B-69509960AFAB01L6PY</basicUdiDi>
    <tradeName>D-69509960AFAB01L6PY</tradeName>
    <deviceName>Influenza A/B  Detection Kit (Direct 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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFAB01-AOG48E; AFAB01-AOG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:52:38.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69509960AFAB03LAQW</udiDi>
    <basicUdiDi>B-69509960AFAB03LAQW</basicUdiDi>
    <tradeName>D-69509960AFAB03LAQW</tradeName>
    <deviceName>Influenza A/B 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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFAB03-AOG48E; AFAB03-AOG96E; AFAB03D-AOG48E; AFAB03D-AOG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:52:34.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69509960ACAB04DJXYT</udiDi>
    <basicUdiDi>B-69509960ACAB04DJXYT</basicUdiDi>
    <tradeName>D-69509960ACAB04DJXYT</tradeName>
    <deviceName>SARS-CoV-2 &amp; Influenza A/B 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>W0105090601</emdnCode>
    <emdnDescription>CORONAVIRUS / INFLUENZA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACAB04D-BOG48E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:52:17.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69384449ROTA3Y</udiDi>
    <basicUdiDi>B-69384449ROTA3Y</basicUdiDi>
    <tradeName>D-69384449ROTA3Y</tradeName>
    <deviceName>One Step Rotavirus Test</deviceName>
    <manufacturerName>Equinox Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018901</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RH-ROTA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:51:42.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>6970277510023AXW</udiDi>
    <basicUdiDi>B-6970277510023AXW</basicUdiDi>
    <tradeName>6970277510023AXW</tradeName>
    <deviceName>Malaria P.f./P.v. Rapid Test Dipstick</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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMPV-401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:50:32.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757993821RC</udiDi>
    <basicUdiDi>B-693757993821RC</basicUdiDi>
    <tradeName>Influenza A/Influenza B (FluA+B) Antigens Rapid Test Kit</tradeName>
    <deviceName>Influenza A/Influenza B (FluA+B) Antigens Rapid Test Kit</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Flu Cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:26.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757991703QP</udiDi>
    <basicUdiDi>B-693757991703QP</basicUdiDi>
    <tradeName>Diagnostic Kit for Pan/ P.falciparum Antigen (Colloidal Gold)</tradeName>
    <deviceName>Diagnostic Kit for Pan/ P.falciparum Antigen (Colloidal Gold)</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MA-Pan/Pf 50170301 MA-Pan/Pf 25170302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:16.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757991702QM</udiDi>
    <basicUdiDi>B-693757991702QM</basicUdiDi>
    <tradeName>Diagnostic Kit for P.falciparum Antigen （Colloidal Gold)</tradeName>
    <deviceName>Diagnostic Kit for P.falciparum Antigen （Colloidal Gold)</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MA-Pf 50170101 MA-Pf 25170102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:14.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757991701QK</udiDi>
    <basicUdiDi>B-693757991701QK</basicUdiDi>
    <tradeName>Diagnostic Kit for P.falciparum /P.vivax Antigen(Colloidal Gold)</tradeName>
    <deviceName>Diagnostic Kit for P.falciparum /P.vivax Antigen(Colloidal Gold)</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MA-Pf/Pv 50170201 MA-Pf/Pv 25170202</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:12.461Z</lastUpdated>
  </row>
</eudamedExport>