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<eudamedExport entity="devices">
  <row>
    <udiDi>16972235840038</udiDi>
    <basicUdiDi>B-16972235840038</basicUdiDi>
    <tradeName>COVID-19/FluA/FluB Antigen Detection Kit(Colloidal Gold)</tradeName>
    <deviceName>COVID-19/FluA/FluB Antigen Detection Kit(Colloidal Gold)</deviceName>
    <manufacturerName>Zhuhai Lituo Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026852</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LCV07</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:04.962Z</lastUpdated>
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  <row>
    <udiDi>15065023763143</udiDi>
    <basicUdiDi>B-15065023763143</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>Rotavirus Rapid Test (LFA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV10015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:34:15.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763075</udiDi>
    <basicUdiDi>B-15065023763075</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>ADV Antigen Rapid Test (LFA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV10008</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:34:03.330Z</lastUpdated>
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  <row>
    <udiDi>14560189216652</udiDi>
    <basicUdiDi>B-14560189216652</basicUdiDi>
    <tradeName>14560189216652</tradeName>
    <deviceName>CL AIA-PACK Anti-SARS-CoV-2-NP TEST CUP</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029179</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:04:02.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>14560189216645</udiDi>
    <basicUdiDi>B-14560189216645</basicUdiDi>
    <tradeName>14560189216645</tradeName>
    <deviceName>CL AIA-PACK Anti-SARS-CoV-2-SP-IgG TEST CUP</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029178</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:04:01.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>14560189216362</udiDi>
    <basicUdiDi>B-14560189216362</basicUdiDi>
    <tradeName>14560189216362</tradeName>
    <deviceName>CL AIA-PACK Anti-SARS-CoV-2-SP-IgG ADJUSTER SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029272</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:03:55.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>14560189216294</udiDi>
    <basicUdiDi>B-14560189216294</basicUdiDi>
    <tradeName>14560189216294</tradeName>
    <deviceName>CL AIA-PACK Anti-SARS-CoV-2-NP ADJUSTER SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029270</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:03:47.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-114302LW</udiDi>
    <basicUdiDi>B-114302LW</basicUdiDi>
    <tradeName>Reageana DOBRAVA-HANTAAN IgG EIA</tradeName>
    <deviceName>Reagena DOBRAVA-HANTAAN IgG EIA</deviceName>
    <manufacturerName>Reagena Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000002804</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>114302</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:48:41.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-114301LU</udiDi>
    <basicUdiDi>B-114301LU</basicUdiDi>
    <tradeName>Reagena PUUMALA IgG EIA</tradeName>
    <deviceName>Reagena PUUMALA IgG EIA</deviceName>
    <manufacturerName>Reagena Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000002804</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>114301</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:48:40.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-114202LR</udiDi>
    <basicUdiDi>B-114202LR</basicUdiDi>
    <tradeName>Reagena DOBRAVA-HANTAAN IgM EIA</tradeName>
    <deviceName>Reagena DOBRAVA-HANTAAN IgM EIA</deviceName>
    <manufacturerName>Reagena Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000002804</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>114202</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:48:35.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-114201LP</udiDi>
    <basicUdiDi>B-114201LP</basicUdiDi>
    <tradeName>Reagena PUUMALA IgM EIA</tradeName>
    <deviceName>Reagena PUUMALA IgM EIA</deviceName>
    <manufacturerName>Reagena Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000002804</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>114201</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:48:34.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013959550</udiDi>
    <basicUdiDi>B-08885013959550</basicUdiDi>
    <tradeName>RapidKey COVID-19 Antigen Self Test (25)</tradeName>
    <deviceName>RapidKey COVID-19 Antigen Self Test (25)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301115</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:19:58.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013959543</udiDi>
    <basicUdiDi>B-08885013959543</basicUdiDi>
    <tradeName>RapidKey COVID-19 Antigen Self Test (7)</tradeName>
    <deviceName>RapidKey COVID-19 Antigen Self Test (7)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:19:54.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013959529</udiDi>
    <basicUdiDi>B-08885013959529</basicUdiDi>
    <tradeName>RapidKey COVID-19 Antigen Self Test (2)</tradeName>
    <deviceName>RapidKey COVID-19 Antigen Self Test (2)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301112</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:19:53.779Z</lastUpdated>
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  <row>
    <udiDi>08885013959536</udiDi>
    <basicUdiDi>B-08885013959536</basicUdiDi>
    <tradeName>RapidKey COVID-19 Antigen Self Test (5)</tradeName>
    <deviceName>RapidKey COVID-19 Antigen Self Test (5)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301113</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:19:53.149Z</lastUpdated>
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  <row>
    <udiDi>08885013959512</udiDi>
    <basicUdiDi>B-08885013959512</basicUdiDi>
    <tradeName>RapidKey COVID-19 Antigen Self Test (1)</tradeName>
    <deviceName>RapidKey COVID-19 Antigen Self Test (1)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:19:52.960Z</lastUpdated>
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    <udiDi>08435440259060</udiDi>
    <basicUdiDi>84354402CLIGASTROB_RTV46</basicUdiDi>
    <tradeName>CerTest CLIA Rotavirus Ag</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-RTV000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:17:05.130Z</lastUpdated>
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  <row>
    <udiDi>08809317541181</udiDi>
    <basicUdiDi>B-08809317541181</basicUdiDi>
    <tradeName>BioTracer™ Dengue Combo Rapid Card</tradeName>
    <deviceName>17311</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17311</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:43:36.275Z</lastUpdated>
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    <udiDi>08809317541174</udiDi>
    <basicUdiDi>B-08809317541174</basicUdiDi>
    <tradeName>BioTracer™ Dengue NS1 Ag Rapid Card</tradeName>
    <deviceName>17212</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17212</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:43:35.468Z</lastUpdated>
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  <row>
    <udiDi>08809317541167</udiDi>
    <basicUdiDi>B-08809317541167</basicUdiDi>
    <tradeName>BioTracer™ Dengue IgG/IgM Rapid Card</tradeName>
    <deviceName>17112</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17112</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:43:34.690Z</lastUpdated>
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</eudamedExport>