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<eudamedExport entity="devices">
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    <basicUdiDi>B-06977903340417</basicUdiDi>
    <tradeName>06977903340417</tradeName>
    <deviceName>Dengue IgM/IgG Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110407C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:31:03.826Z</lastUpdated>
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  <row>
    <udiDi>06977903340325</udiDi>
    <basicUdiDi>B-06977903340325</basicUdiDi>
    <tradeName>06977903340325</tradeName>
    <deviceName>Dengue NS1 Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110405C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:31:02.223Z</lastUpdated>
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  <row>
    <udiDi>06977903340318</udiDi>
    <basicUdiDi>B-06977903340318</basicUdiDi>
    <tradeName>06977903340318</tradeName>
    <deviceName>Dengue NS1 Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110405C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:31:01.423Z</lastUpdated>
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    <udiDi>06977903340226</udiDi>
    <basicUdiDi>B-06977903340226</basicUdiDi>
    <tradeName>06977903340226</tradeName>
    <deviceName>LH Ovulation Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110304C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:30:59.819Z</lastUpdated>
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  <row>
    <udiDi>06977903340219</udiDi>
    <basicUdiDi>B-06977903340219</basicUdiDi>
    <tradeName>06977903340219</tradeName>
    <deviceName>LH Ovulation Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110304C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:30:57.414Z</lastUpdated>
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  <row>
    <udiDi>06977903340110</udiDi>
    <basicUdiDi>B-06977903340110</basicUdiDi>
    <tradeName>06977903340110</tradeName>
    <deviceName>HCG Pregnancy Rapid Test Card/ HCG Pregnancy Rapid Test Strip/ HCG Pregnancy Rapid Test Midstream</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110302C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:30:55.812Z</lastUpdated>
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  <row>
    <udiDi>06977903340127</udiDi>
    <basicUdiDi>B-06977903340127</basicUdiDi>
    <tradeName>06977903340127</tradeName>
    <deviceName>HCG Pregnancy Rapid Test Card/ HCG Pregnancy Rapid Test Strip/ HCG Pregnancy Rapid Test Midstream</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110302C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:30:55.018Z</lastUpdated>
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  <row>
    <udiDi>06977738300006</udiDi>
    <basicUdiDi>B-06977738300006</basicUdiDi>
    <tradeName>06977738300006</tradeName>
    <deviceName>PLAU/SPP1/MMP1 Gene Detection Kit (Fluorescent PCR)</deviceName>
    <manufacturerName>Shanghai Focusgen Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000044043</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010110</emdnCode>
    <emdnDescription>IMMUNOELECTROPHORESIS KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48 tests/box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:29:52.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977738300013</udiDi>
    <basicUdiDi>B-06977738300013</basicUdiDi>
    <tradeName>06977738300013</tradeName>
    <deviceName>PLAU/SPP1/MMP1 Gene Detection Kit (Fluorescent PCR)</deviceName>
    <manufacturerName>Shanghai Focusgen Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000044043</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010110</emdnCode>
    <emdnDescription>IMMUNOELECTROPHORESIS KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96 tests/box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:29:50.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977731460264</udiDi>
    <basicUdiDi>B-06977731460264</basicUdiDi>
    <tradeName>06977731460264</tradeName>
    <deviceName>STERILE CONTAINER</deviceName>
    <manufacturerName>Enlightening Pallet Industry Co., Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000043508</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05010203</emdnCode>
    <emdnDescription>URINE COLLECTION, CONTAINERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60ML</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:29:36.455Z</lastUpdated>
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  <row>
    <udiDi>06977731460004</udiDi>
    <basicUdiDi>B-06977731460004</basicUdiDi>
    <tradeName>06977731460004</tradeName>
    <deviceName>STERILE CONTAINER</deviceName>
    <manufacturerName>Enlightening Pallet Industry Co., Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000043508</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W05010203</emdnCode>
    <emdnDescription>URINE COLLECTION, CONTAINERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0.1ML</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:29:34.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977644787588</udiDi>
    <basicUdiDi>B-06977644787588</basicUdiDi>
    <tradeName>Cytokeratin Pan Antibody Reagent</tradeName>
    <deviceName>Cytokeratin Pan Antibody Reagent</deviceName>
    <manufacturerName>Shenzhen Dakewe Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002174</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4910893</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:27:13.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977644787540</udiDi>
    <basicUdiDi>B-06977644787540</basicUdiDi>
    <tradeName>CK20 Antibody Reagent</tradeName>
    <deviceName>CK20 Antibody Reagent</deviceName>
    <manufacturerName>Shenzhen Dakewe Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002174</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4910373</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:27:13.053Z</lastUpdated>
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  <row>
    <udiDi>06977644783948</udiDi>
    <basicUdiDi>B-06977644783948</basicUdiDi>
    <tradeName>Ki-67 Antibody Reagent</tradeName>
    <deviceName>Ki-67 Antibody Reagent</deviceName>
    <manufacturerName>Shenzhen Dakewe Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002174</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4910103</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:27:08.251Z</lastUpdated>
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  <row>
    <udiDi>06977644783931</udiDi>
    <basicUdiDi>B-06977644783931</basicUdiDi>
    <tradeName>Ki-67 Antibody Reagent</tradeName>
    <deviceName>Ki-67 Antibody Reagent</deviceName>
    <manufacturerName>Shenzhen Dakewe Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002174</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4910102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:27:07.447Z</lastUpdated>
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    <udiDi>06977597620505</udiDi>
    <basicUdiDi>B-06977597620505</basicUdiDi>
    <tradeName>06977597620505</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis antisera for quality control（Group Z）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:27:06.652Z</lastUpdated>
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    <udiDi>06977597620499</udiDi>
    <basicUdiDi>B-06977597620499</basicUdiDi>
    <tradeName>06977597620499</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis antisera for quality control（Group X）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:27:05.839Z</lastUpdated>
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  <row>
    <udiDi>06977597620482</udiDi>
    <basicUdiDi>B-06977597620482</basicUdiDi>
    <tradeName>06977597620482</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis antisera for quality control（Group D）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:27:01.843Z</lastUpdated>
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  <row>
    <udiDi>06977597620475</udiDi>
    <basicUdiDi>B-06977597620475</basicUdiDi>
    <tradeName>06977597620475</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis antisera for quality control（Group W135）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:27:01.039Z</lastUpdated>
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  <row>
    <udiDi>06977597620468</udiDi>
    <basicUdiDi>B-06977597620468</basicUdiDi>
    <tradeName>06977597620468</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis antisera for quality control(Group Y)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:27:00.235Z</lastUpdated>
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