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<eudamedExport entity="devices">
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    <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>
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  <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>
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  <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>
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  <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>
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  <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>
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  <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>
  <row>
    <udiDi>D-6430030990424TT</udiDi>
    <basicUdiDi>B-6430030990424TT</basicUdiDi>
    <tradeName>Actim® Influenza A&amp;B</tradeName>
    <deviceName>Actim® Influenza A&amp;B</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>32837ETAC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:42:49.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6430030990417TW</udiDi>
    <basicUdiDi>B-6430030990417TW</basicUdiDi>
    <tradeName>Actim® Influenza A&amp;B</tradeName>
    <deviceName>Actim® Influenza A&amp;B</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>32836ETAC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:42:48.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6430030990264TV</udiDi>
    <basicUdiDi>B-6430030990264TV</basicUdiDi>
    <tradeName>Actim® Influenza A&amp;B</tradeName>
    <deviceName>Actim® Influenza A&amp;B</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>32834ETAC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:42:29.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6430030990240TF</udiDi>
    <basicUdiDi>B-6430030990240TF</basicUdiDi>
    <tradeName>Actim® Influenza A&amp;B</tradeName>
    <deviceName>Actim® Influenza A&amp;B</deviceName>
    <manufacturerName>Actim Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024323</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>32832ETAC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:42:29.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230182723972</udiDi>
    <basicUdiDi>B-62230182723972</basicUdiDi>
    <tradeName>HAV IgM Rapid Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>HAV IgM Rapid Test Cassette (Serum/Plasma)</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-788 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:38:37.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230182723804</udiDi>
    <basicUdiDi>B-62230182723804</basicUdiDi>
    <tradeName>H. pylori Ag Rapid Test Cassette (Fecal Specimen)</tradeName>
    <deviceName>H. pylori Ag Rapid Test Cassette (Fecal Specimen)</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-794 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:38:33.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230182723590</udiDi>
    <basicUdiDi>B-62230182723590</basicUdiDi>
    <tradeName>Malaria Antigen Test (Whole Blood) For Plasmodium falciparum &amp; vivax</tradeName>
    <deviceName>Malaria Antigen Test (Whole Blood) For Plasmodium falciparum &amp; vivax</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-796 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:38:31.125Z</lastUpdated>
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</eudamedExport>