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<eudamedExport entity="devices">
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    <udiDi>08800111715754</udiDi>
    <basicUdiDi>88001117IPBA03QA04YD</basicUdiDi>
    <tradeName>08800111715754</tradeName>
    <deviceName>STANDARD™ Q COVID-19 Ag Test 2.0</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q-NCOV-07G/ 09COV173D</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:41:40.936Z</lastUpdated>
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  <row>
    <udiDi>08800111715747</udiDi>
    <basicUdiDi>88001117IPBA01QA04XP</basicUdiDi>
    <tradeName>08800111715747</tradeName>
    <deviceName>STANDARD™ Q COVID-19 Ag Test 2.0</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q-NCOV-07G/ 09COV172D</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:41:40.126Z</lastUpdated>
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  <row>
    <udiDi>06933289816809</udiDi>
    <basicUdiDi>69332898CE1606FH</basicUdiDi>
    <tradeName>06933289816809</tradeName>
    <deviceName>2019-nCoV Antigen Test (Lateral Flow Method)</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</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>W634P0024</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:29:50.929Z</lastUpdated>
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    <udiDi>06933289816816</udiDi>
    <basicUdiDi>69332898CE1606FH</basicUdiDi>
    <tradeName>06933289816816</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</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>W634P0025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:58:15.410Z</lastUpdated>
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  <row>
    <udiDi>06933289816823</udiDi>
    <basicUdiDi>69332898CE1606FH</basicUdiDi>
    <tradeName>06933289816823</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</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>W634P0026</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:58:15.386Z</lastUpdated>
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  <row>
    <udiDi>D-nvm-243103N-25PARX</udiDi>
    <basicUdiDi>B-nvm-243103N-25PARX</basicUdiDi>
    <tradeName>NADAL® COVID-19 Ag Test</tradeName>
    <deviceName>COVID-19 Ag Test</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>243103N-25PA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:27:59.773Z</lastUpdated>
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  <row>
    <udiDi>D-nvm-243001N-10TU</udiDi>
    <basicUdiDi>B-nvm-243001N-10TU</basicUdiDi>
    <tradeName>NADAL® COVID-19 IgG/IgM Test</tradeName>
    <deviceName>COVID-19 IgG/IgM Test</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090502</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIBODY (AB) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>243001N-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:27:58.951Z</lastUpdated>
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  <row>
    <udiDi>D-VCD25-01-0132R</udiDi>
    <basicUdiDi>B-VCD25-01-0132R</basicUdiDi>
    <tradeName>SARS-CoV-2 S-RBD IgG Ab Rapid Test</tradeName>
    <deviceName>SARS-CoV-2 S-RBD IgG Ab Rapid Test</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090502</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIBODY (AB) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCD25-01-013</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:13:27.526Z</lastUpdated>
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  <row>
    <udiDi>D-VCD24-01-01326</udiDi>
    <basicUdiDi>B-VCD24-01-01326</basicUdiDi>
    <tradeName>SARS-CoV-2 IgG Rapid Test</tradeName>
    <deviceName>SARS-CoV-2 IgG Rapid Test</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090502</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIBODY (AB) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCD24-01-013</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:13:22.729Z</lastUpdated>
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  <row>
    <udiDi>D-SC2GMAb801B9</udiDi>
    <basicUdiDi>B-SC2GMAb801B9</basicUdiDi>
    <tradeName>COVID-19 IgG/IgM Rapid Test</tradeName>
    <deviceName>COVID-19 IgG/IgM 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>W0105090502</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIBODY (AB) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC2GMAb801</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:39:28.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-INCP-RG502CE</udiDi>
    <basicUdiDi>B-INCP-RG502CE</basicUdiDi>
    <tradeName>SARS-CoV-2 (COVID-19) Antigen Rapid Test</tradeName>
    <deviceName>SARS-CoV-2 (COVID-19) Antigen Rapid Test</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>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INCP-RG502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:39:26.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD149XU</udiDi>
    <basicUdiDi>B-GKPD149XU</basicUdiDi>
    <tradeName>SARS-CoV-2  Ag Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>SARS-CoV-2  Ag Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD149</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:33.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD125XE</udiDi>
    <basicUdiDi>B-GKPD125XE</basicUdiDi>
    <tradeName>MERS-CoV Antigen Rapid Test Kit</tradeName>
    <deviceName>MERS-CoV Antigen Rapid Test Kit</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD125</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:37:40.617Z</lastUpdated>
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  <row>
    <udiDi>D-GCCOV-D503aHGGU</udiDi>
    <basicUdiDi>B-GCCOV-D503aHGGU</basicUdiDi>
    <tradeName>Digital COVID-19 Ag Rapid Test (Swab)</tradeName>
    <deviceName>Digital COVID-19 Ag Rapid Test (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>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-D503a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:20.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-D503a4W</udiDi>
    <basicUdiDi>B-GCCOV-D503a4W</basicUdiDi>
    <tradeName>Digital COVID-19 Ag Rapid Test (Swab)</tradeName>
    <deviceName>Digital COVID-19 Ag Rapid Test (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>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-D503a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:17.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-702aHG5A</udiDi>
    <basicUdiDi>B-GCCOV-702aHG5A</basicUdiDi>
    <tradeName>COVID-19 Ag Rapid Test Cassette (Oral Fluid)</tradeName>
    <deviceName>COVID-19 Ag Rapid Test Cassette (Oral Fluid)</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>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-702a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:15.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-702a4Q</udiDi>
    <basicUdiDi>B-GCCOV-702a4Q</basicUdiDi>
    <tradeName>COVID-19 Ag Rapid Test Cassette (Oral Fluid)</tradeName>
    <deviceName>COVID-19 Ag Rapid Test Cassette (Oral Fluid)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-702a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:15.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-503a4D</udiDi>
    <basicUdiDi>B-GCCOV-503a4D</basicUdiDi>
    <tradeName>Smart Rapid COVID-19 Ag Test Device</tradeName>
    <deviceName>Smart Rapid COVID-19 Ag Test Device</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>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-503a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:13.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-503aHG4P</udiDi>
    <basicUdiDi>B-GCCOV-503aHG4P</basicUdiDi>
    <tradeName>Smart Rapid COVID-19 Ag Test Device</tradeName>
    <deviceName>Smart Rapid COVID-19 Ag Test Device</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>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-503a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:11.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-502a4A</udiDi>
    <basicUdiDi>B-GCCOV-502a4A</basicUdiDi>
    <tradeName>Coronavirus Ag Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Coronavirus Ag Rapid Test Cassette (Swab)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:09.604Z</lastUpdated>
  </row>
</eudamedExport>