<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06979890910673</udiDi>
    <basicUdiDi>69798909110006CP</basicUdiDi>
    <tradeName>Influenza A/B Antigen Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medotex Biotech (HangZhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051631</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</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>FLU-522b-25M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:54:11.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IINA-R5257T</udiDi>
    <basicUdiDi>B-IINA-R5257T</basicUdiDi>
    <tradeName>Influenza A/B+H1N1 Combo Rapid Test Cassette</tradeName>
    <deviceName>Influenza A/B+H1N1 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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IINA-R525</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:33:12.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IFLA-R502(AT)TC</udiDi>
    <basicUdiDi>B-IFLA-R502(AT)TC</basicUdiDi>
    <tradeName>Influenza A Rapid Test Cassette</tradeName>
    <deviceName>Influenza A 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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFLA-R502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-28T03:47:15.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IINA-525EE</udiDi>
    <basicUdiDi>B-IINA-525EE</basicUdiDi>
    <tradeName>Influenza A/B+H1N1 Combo Rapid Test Cassette</tradeName>
    <deviceName>Influenza A/B+H1N1 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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IINA-525</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:05:41.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IIN-501(AT)A3</udiDi>
    <basicUdiDi>B-IIN-501(AT)A3</basicUdiDi>
    <tradeName>Influenza A+B Rapid Test Dipstick</tradeName>
    <deviceName>Influenza A+B Rapid Test Dipstick</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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IIN-501</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:05:40.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IFLA-502BM</udiDi>
    <basicUdiDi>B-IFLA-502BM</basicUdiDi>
    <tradeName>Influenza A Rapid Test Cassette</tradeName>
    <deviceName>Influenza A 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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFLA-502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:05:38.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IFLA-501BK</udiDi>
    <basicUdiDi>B-IFLA-501BK</basicUdiDi>
    <tradeName>Influenza A Rapid Test Dipstick</tradeName>
    <deviceName>Influenza A Rapid Test Dipstick</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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFLA-501</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:05:34.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977775222316</udiDi>
    <basicUdiDi>693869768062S6</basicUdiDi>
    <tradeName>06977775222316</tradeName>
    <deviceName>Influenza A+B Antigen Combo Rapid Test</deviceName>
    <manufacturerName>Shanghai Chemtron Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018072</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>8062C01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:06:21.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972412616787</udiDi>
    <basicUdiDi>697241261IFL-A502JL</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName>Influenza A Antigen Rapid Test</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-A502-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:05:26.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972412614301</udiDi>
    <basicUdiDi>697241261IFL-502BQ</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName>Influenza A/B Antigen Rapid Test</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-502-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:05:20.829Z</lastUpdated>
  </row>
  <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-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-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-697603130101A0201EG7SK</udiDi>
    <basicUdiDi>B-697603130101A0201EG7SK</basicUdiDi>
    <tradeName>D-697603130101A0201EG7SK</tradeName>
    <deviceName>Influenza A/B Virus Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</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>101A0201EY,101A0201ED</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:16.902Z</lastUpdated>
  </row>
</eudamedExport>