<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04260163315519</udiDi>
    <basicUdiDi>B-04260163315519</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2 Antigen Test Card (1 Test Box)</tradeName>
    <deviceName>Rapid SARS-CoV-2 Antigen Test Card</deviceName>
    <manufacturerName>MP Biomedicals Germany GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020991</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07AG6001BS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T19:39:21.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260163315502</udiDi>
    <basicUdiDi>B-04260163315502</basicUdiDi>
    <tradeName>Rapid SARS-CoV-2 Antigen Test Card (20 tests per box)</tradeName>
    <deviceName>Rapid SARS-CoV-2 Antigen Test Card</deviceName>
    <manufacturerName>MP Biomedicals Germany GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020991</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07AG6020BS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T19:39:21.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>08887581000740</udiDi>
    <basicUdiDi>B-08887581000740</basicUdiDi>
    <tradeName>MP Diagnostics ASSURE H. pylori Rapid Test</tradeName>
    <deviceName>MP Diagnostics ASSURE H. pylori Rapid Test</deviceName>
    <manufacturerName>MP Biomedicals Asia Pacific Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024819</manufacturerSrn>
    <authorisedRepresentativeName>MP Biomedicals Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000020992</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>43490-020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T14:19:04.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111725746</udiDi>
    <basicUdiDi>88001117ISCA01QA032G</basicUdiDi>
    <tradeName>STANDARD™ Q COVID-19 Ag Home Test</tradeName>
    <deviceName>STANDARD™ Q COVID-19 Ag Home Test</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q-NCOV-03G/ 09COV130</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T03:07:08.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111725753</udiDi>
    <basicUdiDi>88001117ISCA01QA032G</basicUdiDi>
    <tradeName>STANDARD™ Q COVID-19 Ag Home Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q-NCOV-03G/ 09COV130H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T03:06:14.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111725760</udiDi>
    <basicUdiDi>88001117ISCA01QA032G</basicUdiDi>
    <tradeName>STANDARD™ Q COVID-19 Ag Home Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q-NCOV-03G/ 09COV130J</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T03:06:14.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111725777</udiDi>
    <basicUdiDi>88001117ISCA01QA032G</basicUdiDi>
    <tradeName>STANDARD™ Q COVID-19 Ag Home Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q-NCOV-03G/ 09COV130D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T03:06:14.411Z</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>06976232252194</udiDi>
    <basicUdiDi>B-06976232252194</basicUdiDi>
    <tradeName>Acmex</tradeName>
    <deviceName>Covid-19/Influenza A+B/RSV Antigen Combo Rapid Test</deviceName>
    <manufacturerName>Acmex Bio-Technology (Chongqing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037745</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA03-88-422P20</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:22:19.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RV-G45bZV</udiDi>
    <basicUdiDi>B-RV-G45bZV</basicUdiDi>
    <tradeName>COVID-19/ InfluenzaA+B/RSV Antigen Combo Rapid Test</tradeName>
    <deviceName>COVID-19/ Influenza A+B/RSV Antigen Combo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV-G45b</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:09:58.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-VC01C66C</udiDi>
    <basicUdiDi>B-L11-VC01C66C</basicUdiDi>
    <tradeName>One Step Vibrio Cholerae O139,O1 Ogawa &amp; Inaba Combo Test</tradeName>
    <deviceName>One Step Vibrio Cholerae O139,O1 Ogawa &amp; Inaba Combo Test</deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L11-VC01C6</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:09:40.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IVCAI-R602BC</udiDi>
    <basicUdiDi>B-IVCAI-R602BC</basicUdiDi>
    <tradeName>Vibrio Cholerae O1 Inaba (VC O1 Inaba) Rapid Test Cassette</tradeName>
    <deviceName>Vibrio Cholerae O1 Inaba (VC O1 Inaba) Rapid Test Cassette</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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVCAI-R602</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:06:59.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IVCB-R6029V</udiDi>
    <basicUdiDi>B-IVCB-R6029V</basicUdiDi>
    <tradeName>Vibrio cholerae O139 (VC O139) Rapid Test Cassette</tradeName>
    <deviceName>Vibrio cholerae O139 (VC O139) Rapid Test Cassette</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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVCB-R602</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:06:57.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IVCAO-R602DS</udiDi>
    <basicUdiDi>B-IVCAO-R602DS</basicUdiDi>
    <tradeName>Vibrio Cholerae O1 Ogawa (VC O1 Ogawa) Rapid Test Cassette</tradeName>
    <deviceName>Vibrio Cholerae O1 Ogawa (VC O1 Ogawa) Rapid Test Cassette</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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVCAO-R602</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:06:55.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IVCAB-R6258V</udiDi>
    <basicUdiDi>B-IVCAB-R6258V</basicUdiDi>
    <tradeName>Vibrio cholerae O1/O139 Combo Rapid Test Cassette</tradeName>
    <deviceName>Vibrio cholerae O1/O139 Combo Rapid Test Cassette</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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVCAB-R625</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:06:53.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IVCA-R6029G</udiDi>
    <basicUdiDi>B-IVCA-R6029G</basicUdiDi>
    <tradeName>Vibrio cholerae O1 (VC O1) Rapid Test Cassette</tradeName>
    <deviceName>Vibrio cholerae O1 (VC O1) Rapid Test Cassette</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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVCA-R602</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:06:47.792Z</lastUpdated>
  </row>
</eudamedExport>