<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06972412616879</udiDi>
    <basicUdiDi>697241261IFL-A502JL</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFL-A502-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:53:21.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972412618088</udiDi>
    <basicUdiDi>697241261IFL-502BQ</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFL-502-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:53:21.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICGC-62598</udiDi>
    <basicUdiDi>B-ICGC-62598</basicUdiDi>
    <tradeName>Cryptosporidium and Giardia lamblia Combo Rapid Test Cassette</tradeName>
    <deviceName>Cryptosporidium and Giardia lamblia Combo Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</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>ICGC-625</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-21T04:29:54.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SW02-FLAB(PRO)CM</udiDi>
    <basicUdiDi>B-SW02-FLAB(PRO)CM</basicUdiDi>
    <tradeName>Flu A+B Test (Swab/Nasal Aspirate)</tradeName>
    <deviceName>Flu A+B Test (Swab/Nasal Aspirate)</deviceName>
    <manufacturerName>Aceso Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045175</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</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>SW02-FLAB(PRO)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:41:08.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCFLU(AH5)-502aOGKU</udiDi>
    <basicUdiDi>B-GCFLU(AH5)-502aOGKU</basicUdiDi>
    <tradeName>Influenza A (H5) Ag Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Influenza A (H5) Ag Rapid Test Cassette (Swab)</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>GCFLU(AH5)-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:40:44.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCFLU(AH5)-502aHGK7</udiDi>
    <basicUdiDi>B-GCFLU(AH5)-502aHGK7</basicUdiDi>
    <tradeName>Influenza A (H5) Ag Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Influenza A (H5) Ag Rapid Test Cassette (Swab)</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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFLU(AH5)-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:40:40.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCFLU(A)-U502aOG5L</udiDi>
    <basicUdiDi>B-GCFLU(A)-U502aOG5L</basicUdiDi>
    <tradeName>Flu A Ag Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Flu A Ag Rapid Test Cassette (Swab)</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>GCFLU(A)-U502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:40:39.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCFLU(A)-U502aHG4X</udiDi>
    <basicUdiDi>B-GCFLU(A)-U502aHG4X</basicUdiDi>
    <tradeName>Flu A Ag Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Flu A Ag Rapid Test Cassette (Swab)</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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFLU(A)-U502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:40:38.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HIFL-522E6</udiDi>
    <basicUdiDi>B-HIFL-522E6</basicUdiDi>
    <tradeName>D-HIFL-522E6</tradeName>
    <deviceName>Influenza A+B Rapid Test</deviceName>
    <manufacturerName>Hysen Biotech.Inc</manufacturerName>
    <manufacturerSrn>KR-MF-000048224</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</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>HIFL-522</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:03:48.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-502a-H2OGEEW</udiDi>
    <basicUdiDi>B-GCCOV-502a-H2OGEEW</basicUdiDi>
    <tradeName>Rapid COVID-19 (Antigen) Self-Test</tradeName>
    <deviceName>Rapid COVID-19 (Antigen) Self-Test</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-502a-H2OGE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:03:47.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A5195</udiDi>
    <basicUdiDi>B-A5195</basicUdiDi>
    <tradeName>D-A5195</tradeName>
    <deviceName>INDICAID™ HPV 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ HPV Rapid Antigen Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:54.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A067DF</udiDi>
    <basicUdiDi>B-A067DF</basicUdiDi>
    <tradeName>D-A067DF</tradeName>
    <deviceName>INDICAID™ Chikungunya Rapid Antibody 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Chikungunya Rapid Antibody Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:21.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A066DD</udiDi>
    <basicUdiDi>B-A066DD</basicUdiDi>
    <tradeName>D-A066DD</tradeName>
    <deviceName>INDICAID™ Chikungunya 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Chikungunya Rapid Antigen Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:20.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0593VFD</udiDi>
    <basicUdiDi>B-697994388Ir0593VFD</basicUdiDi>
    <tradeName>D-697994388Ir0593VFD</tradeName>
    <deviceName>HSV Herpes Simplex Virus Ab Test Kit</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>W0105099001</emdnCode>
    <emdnDescription>CMV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir059</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:55.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0493SEY</udiDi>
    <basicUdiDi>B-697994388Ir0493SEY</basicUdiDi>
    <tradeName>D-697994388Ir0493SEY</tradeName>
    <deviceName>COVID-19 (2019n-Cov) Antigen Detection Kit</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>W0105099001</emdnCode>
    <emdnDescription>CMV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir049</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:43.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0453JDS</udiDi>
    <basicUdiDi>B-697994388Ir0453JDS</basicUdiDi>
    <tradeName>D-697994388Ir0453JDS</tradeName>
    <deviceName>RSV Respiratory Syncytial Virus Ag Test Kit</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>W0105099002</emdnCode>
    <emdnDescription>RSV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:33.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0433ED6</udiDi>
    <basicUdiDi>B-697994388Ir0433ED6</basicUdiDi>
    <tradeName>D-697994388Ir0433ED6</tradeName>
    <deviceName>Influenza A+B Ag Test Kit</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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir043</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:31.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir04038BX</udiDi>
    <basicUdiDi>B-697994388Ir04038BX</basicUdiDi>
    <tradeName>D-697994388Ir04038BX</tradeName>
    <deviceName>Norovirus GI/GII Antigen Detection Kit</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>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:24.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0353FDB</udiDi>
    <basicUdiDi>B-697994388Ir0353FDB</basicUdiDi>
    <tradeName>D-697994388Ir0353FDB</tradeName>
    <deviceName>Adenovirus/Rotavirus Ag Test Panel</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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir035</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:03.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0343DD2</udiDi>
    <basicUdiDi>B-697994388Ir0343DD2</basicUdiDi>
    <tradeName>D-697994388Ir0343DD2</tradeName>
    <deviceName>Rotavirus Ag Test Kit</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>W0105099001</emdnCode>
    <emdnDescription>CMV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir034</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:23:56.269Z</lastUpdated>
  </row>
</eudamedExport>