<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-EGN7101117EW</udiDi>
    <basicUdiDi>B-EGN7101117EW</basicUdiDi>
    <tradeName>D-EGN7101117EW</tradeName>
    <deviceName>SARS-CoV-2 Fluorescent PCR Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EGN7101117</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:47:07.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EGN7101109EX</udiDi>
    <basicUdiDi>B-EGN7101109EX</basicUdiDi>
    <tradeName>D-EGN7101109EX</tradeName>
    <deviceName>SARS-CoV-2 Fluorescent PCR</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EGN7101109</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:51.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBOV-402a54</udiDi>
    <basicUdiDi>B-EBOV-402a54</basicUdiDi>
    <tradeName>Ebola Antigen Rapid Test</tradeName>
    <deviceName>Ebola antigen rapid test</deviceName>
    <manufacturerName>Medotex Biotech (HangZhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051631</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040627</emdnCode>
    <emdnDescription>EBOLA (FILOVIRUS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBOV-402a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:26:34.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D-FIEV71AGD25QH</udiDi>
    <basicUdiDi>B-D-FIEV71AGD25QH</basicUdiDi>
    <tradeName>Enterovirus 71 Ag Test Device-Feces</tradeName>
    <deviceName>Enterovirus 71 Ag Test Device-Feces</deviceName>
    <manufacturerName>Rapid Labs Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026335</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040602</emdnCode>
    <emdnDescription>ENTEROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-FIEV71AGD25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:23.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D-FIEV71AGD10Q4</udiDi>
    <basicUdiDi>B-D-FIEV71AGD10Q4</basicUdiDi>
    <tradeName>Enterovirus 71 Ag Test Device-Feces</tradeName>
    <deviceName>Enterovirus 71 Ag Test Device-Feces</deviceName>
    <manufacturerName>Rapid Labs Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026335</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040602</emdnCode>
    <emdnDescription>ENTEROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-FIEV71AGD10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:21.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D-ASTD1084</udiDi>
    <basicUdiDi>B-D-ASTD1084</basicUdiDi>
    <tradeName>Astrovirus Rapid Test Device – Feces</tradeName>
    <deviceName>Astrovirus Rapid Test Device – Feces</deviceName>
    <manufacturerName>Rapid Labs Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026335</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-ASTD10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:09.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D-ADOD2529</udiDi>
    <basicUdiDi>B-D-ADOD2529</basicUdiDi>
    <tradeName>Adenovirus Rapid Test Device – Feces</tradeName>
    <deviceName>Adenovirus Rapid Test Device – Feces</deviceName>
    <manufacturerName>Rapid Labs Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026335</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-ADOD25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:06.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR022GD</udiDi>
    <basicUdiDi>B-CNMF000054349CR022GD</basicUdiDi>
    <tradeName>Dengue NS1 Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>Dengue NS1 Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:45.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR011G8</udiDi>
    <basicUdiDi>B-CNMF000054349CR011G8</basicUdiDi>
    <tradeName>Dengue IgG/IgM/NS1 Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>Dengue IgG/IgM/NS1 Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:36.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR010G6</udiDi>
    <basicUdiDi>B-CNMF000054349CR010G6</basicUdiDi>
    <tradeName>Dengue IgG/IgM Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>Dengue IgG/IgM Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:34.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNM0000180720002LQ</udiDi>
    <basicUdiDi>B-CNM0000180720002LQ</basicUdiDi>
    <tradeName>Chemtrue ® COVID-19 （SARS-CoV-2）Antigen Rapid Test Kit(Saliva)</tradeName>
    <deviceName>COVID-19 (SARS- CoV-2) Antigen Rapid Test Kit(Saliva)</deviceName>
    <manufacturerName>Shanghai Chemtron Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018072</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8046C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:10:12.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNM0000180720003LS</udiDi>
    <basicUdiDi>B-CNM0000180720003LS</basicUdiDi>
    <tradeName>Chemtrue ® COVID-19 Ag Rapid Test (Colloidal Gold)</tradeName>
    <deviceName>Chemtrue ® COVID-19 Ag Rapid Test (Colloidal Gold)</deviceName>
    <manufacturerName>Shanghai Chemtron Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018072</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8040C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:10:10.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNM0000180720001LN</udiDi>
    <basicUdiDi>B-CNM0000180720001LN</basicUdiDi>
    <tradeName>Chemtrue ®COVID-19 （SARS-CoV-2）Antigen Rapid Test Kit(Nasal Swab)</tradeName>
    <deviceName>COVID-19 ( SARS- CoV-2) Antigen Rapid Test Kit(Nasal Swab)</deviceName>
    <manufacturerName>Shanghai Chemtron Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018072</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8047C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:10:09.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A014CS</udiDi>
    <basicUdiDi>B-A014CS</basicUdiDi>
    <tradeName>INDICAID™ Respiratory Syncytial Virus Rapid Antigen Test</tradeName>
    <deviceName>INDICAID™ Respiratory Syncytial Virus Rapid Antigen Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040605</emdnCode>
    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Respiratory Syncytial Virus Rapid Antigen Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:14:18.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A010CJ</udiDi>
    <basicUdiDi>B-A010CJ</basicUdiDi>
    <tradeName>INDICAID™Norovirus Rapid Antigen Test</tradeName>
    <deviceName>INDICAID™Norovirus Rapid Antigen Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040616</emdnCode>
    <emdnDescription>NOROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™Norovirus Rapid Antigen Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:14:11.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8683735226YSM-AG-103LT</udiDi>
    <basicUdiDi>B-8683735226YSM-AG-103LT</basicUdiDi>
    <tradeName>YASHAMMED® COVID-19 &amp; INF A/B &amp; RSV HOME TEST</tradeName>
    <deviceName>YASHAMMED® COVID-19 &amp; INF A/B &amp; RSV HOME TEST</deviceName>
    <manufacturerName>YASHAMMED MEDİKAL KOZMETİK GIDA İNŞAAT İTHALAT İHRACAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ ANKARA ŞUBESİ</manufacturerName>
    <manufacturerSrn>TR-MF-000032364</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YSM-AG-103</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:58:16.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8683735226YSM-AG-102LR</udiDi>
    <basicUdiDi>B-8683735226YSM-AG-102LR</basicUdiDi>
    <tradeName>YASHAMMED® COVID-19 &amp; INF A/B &amp; RSV TEST</tradeName>
    <deviceName>YASHAMMED® COVID-19 &amp; INF A/B &amp; RSV TEST</deviceName>
    <manufacturerName>YASHAMMED MEDİKAL KOZMETİK GIDA İNŞAAT İTHALAT İHRACAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ ANKARA ŞUBESİ</manufacturerName>
    <manufacturerSrn>TR-MF-000032364</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YSM-AG-102</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:58:15.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8683735226YSM-AG-101LP</udiDi>
    <basicUdiDi>B-8683735226YSM-AG-101LP</basicUdiDi>
    <tradeName>YASHAMMED® COVID-19 RAPID AG NASOPHARYNGEAL TEST</tradeName>
    <deviceName>YASHAMMED® COVID-19 Rapid Ag Nasopharyngeal Test</deviceName>
    <manufacturerName>YASHAMMED MEDİKAL KOZMETİK GIDA İNŞAAT İTHALAT İHRACAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ ANKARA ŞUBESİ</manufacturerName>
    <manufacturerSrn>TR-MF-000032364</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YSM-AG-101</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:58:11.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313276462</udiDi>
    <basicUdiDi>B-86060313276462</basicUdiDi>
    <tradeName>Adenovirus</tradeName>
    <deviceName>Adenovirus</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1813ADN</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:15:21.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313276394</udiDi>
    <basicUdiDi>B-86060313276394</basicUdiDi>
    <tradeName>Astrovirus</tradeName>
    <deviceName>Astrovirus</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040629</emdnCode>
    <emdnDescription>ASTROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1814AST</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:15:20.302Z</lastUpdated>
  </row>
</eudamedExport>