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<eudamedExport entity="devices">
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    <udiDi>08435440200147</udiDi>
    <basicUdiDi>84354402IDXGASTROB_R4T</basicUdiDi>
    <tradeName>CerTest Rotavirus</tradeName>
    <deviceName>CerTest Rotavirus</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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R820001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:18:53.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974167892263</udiDi>
    <basicUdiDi>697416789123145ZT</basicUdiDi>
    <tradeName>06974167892263</tradeName>
    <deviceName>Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA)</deviceName>
    <manufacturerName>Jiangsu Medomics Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030226</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>123145-01-102</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:09:56.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974167892188</udiDi>
    <basicUdiDi>697416789100NQ</basicUdiDi>
    <tradeName>Heltiso TEST COMBO ANTYGENOWY  SARS-COV-2/ GRYPA A/ GRYPA B + ADV/ RSV</tradeName>
    <deviceName>SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)</deviceName>
    <manufacturerName>Jiangsu Medomics Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030226</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>123143-01-102-PL03</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:09:55.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002806</udiDi>
    <basicUdiDi>69509960GCFCRA-T525aDRH6M</basicUdiDi>
    <tradeName>COVID-19/Flu A&amp;B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19/Flu A&amp;B/RSV/Adeno Ag Combo 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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFCRA-T525a-DRH1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:48:36.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002813</udiDi>
    <basicUdiDi>69509960GCFCRA-T525aDRH6M</basicUdiDi>
    <tradeName>COVID-19/Flu A&amp;B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName></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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFCRA-T525a-DRH5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:57:09.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002820</udiDi>
    <basicUdiDi>69509960GCFCRA-T525aDRH6M</basicUdiDi>
    <tradeName>COVID-19/Flu A&amp;B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName></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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFCRA-T525a-DRH7</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:57:09.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002837</udiDi>
    <basicUdiDi>69509960GCFCRA-T525aDRH6M</basicUdiDi>
    <tradeName>COVID-19/Flu A&amp;B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName></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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFCRA-T525a-DRH20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:57:09.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-920002T7</udiDi>
    <basicUdiDi>B-nvm-920002T7</basicUdiDi>
    <tradeName>NADAL® Norovirus GI/GII Test</tradeName>
    <deviceName>Norovirus GI/GII 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>920002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:29:42.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ZIKANS1-W23YD</udiDi>
    <basicUdiDi>B-ZIKANS1-W23YD</basicUdiDi>
    <tradeName>D-ZIKANS1-W23YD</tradeName>
    <deviceName>Zika NS1 Antigen Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZIKA-NS1-W23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:12:40.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ZIKA-D22aHA</udiDi>
    <basicUdiDi>B-ZIKA-D22aHA</basicUdiDi>
    <tradeName>Zika IgG/lgM Antibody Rapid Test</tradeName>
    <deviceName>Zika IgG/lgM Antibody 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZIKA-D22a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:12:37.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MPXV-C91-25MN</udiDi>
    <basicUdiDi>B-WI-MPXV-C91-25MN</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>Monkeypox Virus Antigen Rapid Test Device (Pus Swab)</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</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>WI-MPXV-C91-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:32:30.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MPXV-C42-25L6</udiDi>
    <basicUdiDi>B-WI-MPXV-C42-25L6</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>Monkeypox Virus IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</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>WI-MPXV-C42-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:32:28.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MICR-C86A-25CQ</udiDi>
    <basicUdiDi>B-WI-MICR-C86A-25CQ</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>FLU A/B &amp; SARS-Cov-2 &amp; RSV&amp; ADV &amp; MP Combo Rapid Test Device</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</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>WI-MICR-C86A-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:32:28.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MICR-C85A-25CD</udiDi>
    <basicUdiDi>B-WI-MICR-C85A-25CD</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>FLU A &amp; B &amp; SARS-Cov-2 &amp; RSV&amp; ADV Combo Rapid Test Device</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WI-MICR-C85A-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:32:27.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MICR-C83A-25BP</udiDi>
    <basicUdiDi>B-WI-MICR-C83A-25BP</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>SARS-CoV-2 &amp; Influenza AB Antigen Combo Rapid Test Kit (LFIA)</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</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>WI-MICR-C83A-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:32:23.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MICR-C810C-25U5</udiDi>
    <basicUdiDi>B-WI-MICR-C810C-25U5</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>FLU A/B &amp; SARS-Cov-2 &amp; RSV&amp; ADV &amp;PIV I/III &amp;PIV II &amp;MP &amp; HMV &amp; HRV Combo Rapid Test Device</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</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>WI-MICR-C810C-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:32:22.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MICR-C810C-10TQ</udiDi>
    <basicUdiDi>B-WI-MICR-C810C-10TQ</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>FLU A/B &amp; SARS-Cov-2 &amp; RSV&amp; ADV &amp;PIV I/III &amp;PIV II &amp;MP &amp; HMV &amp; HRV Combo Rapid Test Device</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</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>WI-MICR-C810C-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:32:21.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MICR-C810C-01TP</udiDi>
    <basicUdiDi>B-WI-MICR-C810C-01TP</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>FLU A/B &amp; SARS-Cov-2 &amp; RSV&amp; ADV &amp;PIV I/III &amp;PIV II &amp;MP &amp; HMV &amp; HRV Combo Rapid Test Device</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</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>WI-MICR-C810C-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:32:20.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VPK901KM</udiDi>
    <basicUdiDi>B-VPK901KM</basicUdiDi>
    <tradeName>Monkeypox Virus Nucleic Acid Detection Kit</tradeName>
    <deviceName></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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VPK901-011</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:26:42.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VISM-737UT</udiDi>
    <basicUdiDi>B-VISM-737UT</basicUdiDi>
    <tradeName>SARS-CoV-2/M.pneumoniae IgG/IgM Combo Rapid Test</tradeName>
    <deviceName>SARS-CoV-2/M.pneumoniae IgG/IgM Combo 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VISM-737</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:24:03.354Z</lastUpdated>
  </row>
</eudamedExport>