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<eudamedExport entity="devices">
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    <udiDi>06978168790016</udiDi>
    <basicUdiDi>B-06978168790016</basicUdiDi>
    <tradeName>06978168790016</tradeName>
    <deviceName>COVID-19 Antigen Rapid Detection Kit（Colloidal gold)</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:29.206Z</lastUpdated>
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  <row>
    <udiDi>06978168790009</udiDi>
    <basicUdiDi>B-06978168790009</basicUdiDi>
    <tradeName>06978168790009</tradeName>
    <deviceName>COVID-19 Neutralizing Antibody Rapid Detection Kit（Colloidal gold）</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:28.406Z</lastUpdated>
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    <udiDi>06975491761096</udiDi>
    <basicUdiDi>B-06975491761096</basicUdiDi>
    <tradeName>06975491761096</tradeName>
    <deviceName>Monkeypox Virus (MPXV) IgG/IgM Antibody Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:52:30.743Z</lastUpdated>
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    <udiDi>06975491761089</udiDi>
    <basicUdiDi>B-06975491761089</basicUdiDi>
    <tradeName>06975491761089</tradeName>
    <deviceName>Monkeypox Virus (MPXV) IgG/IgM Antibody Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:52:28.329Z</lastUpdated>
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  <row>
    <udiDi>06975491761072</udiDi>
    <basicUdiDi>B-06975491761072</basicUdiDi>
    <tradeName>06975491761072</tradeName>
    <deviceName>Monkeypox Virus (MPXV) IgG/IgM Antibody Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:52:26.738Z</lastUpdated>
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  <row>
    <udiDi>06975491761065</udiDi>
    <basicUdiDi>B-06975491761065</basicUdiDi>
    <tradeName>06975491761065</tradeName>
    <deviceName>Monkeypox Virus (MPXV) IgG/IgM Antibody Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:52:25.911Z</lastUpdated>
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    <udiDi>06975491761058</udiDi>
    <basicUdiDi>B-06975491761058</basicUdiDi>
    <tradeName>06975491761058</tradeName>
    <deviceName>Monkeypox Virus (MPXV) IgG/IgM Antibody Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 test/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:52:24.311Z</lastUpdated>
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  <row>
    <udiDi>06975491761041</udiDi>
    <basicUdiDi>B-06975491761041</basicUdiDi>
    <tradeName>06975491761041</tradeName>
    <deviceName>Monkeypox Virus (MPXV) Antigen Test (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:52:21.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975491761034</udiDi>
    <basicUdiDi>B-06975491761034</basicUdiDi>
    <tradeName>06975491761034</tradeName>
    <deviceName>Monkeypox Virus (MPXV) Antigen Test (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:52:19.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975491761027</udiDi>
    <basicUdiDi>B-06975491761027</basicUdiDi>
    <tradeName>06975491761027</tradeName>
    <deviceName>Monkeypox Virus (MPXV) Antigen Test (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:52:18.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975491761010</udiDi>
    <basicUdiDi>B-06975491761010</basicUdiDi>
    <tradeName>06975491761010</tradeName>
    <deviceName>Monkeypox Virus (MPXV) Antigen Test (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:52:17.110Z</lastUpdated>
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  <row>
    <udiDi>06975491761003</udiDi>
    <basicUdiDi>B-06975491761003</basicUdiDi>
    <tradeName>06975491761003</tradeName>
    <deviceName>Monkeypox Virus (MPXV) Antigen Test (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 test/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:52:14.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975068490282</udiDi>
    <basicUdiDi>B-06975068490282</basicUdiDi>
    <tradeName>Total IgE Rapid Quantitative Test（Fluorescence Immunoassay）</tradeName>
    <deviceName>Total IgE Rapid Quantitative Test（Fluorescence Immunoassay）</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP068.B1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:30:21.931Z</lastUpdated>
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  <row>
    <udiDi>D-05060599400358HK</udiDi>
    <basicUdiDi>B-05060599400358HK</basicUdiDi>
    <tradeName>Anti-D (IgG &amp; IgM) Monoclonal</tradeName>
    <deviceName>Anti-D (IgG &amp; IgM) Monoclonal</deviceName>
    <manufacturerName>Rapid Labs Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026335</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030201</emdnCode>
    <emdnDescription>RHESUS D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG-D10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:24:54.500Z</lastUpdated>
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    <udiDi>D-05060599400310GP</udiDi>
    <basicUdiDi>B-05060599400310GP</basicUdiDi>
    <tradeName>Anti-A,B Monoclonal</tradeName>
    <deviceName>Anti-A,B Monoclonal</deviceName>
    <manufacturerName>Rapid Labs Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026335</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030102</emdnCode>
    <emdnDescription>ABO SERA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG-AB10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:24:40.018Z</lastUpdated>
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    <udiDi>D-05060599400143GU</udiDi>
    <basicUdiDi>B-05060599400143GU</basicUdiDi>
    <tradeName>Anti-B Monoclonal</tradeName>
    <deviceName>Anti-B Monoclonal</deviceName>
    <manufacturerName>Rapid Labs Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026335</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030101</emdnCode>
    <emdnDescription>ABO GROUPING CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG-B10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:24:39.219Z</lastUpdated>
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    <udiDi>04250861815404</udiDi>
    <basicUdiDi>B-04250861815404</basicUdiDi>
    <tradeName>Anti-A1 for card method Lectin (Dolichos biflorus)</tradeName>
    <deviceName>Anti-A1 for card method Lectin (Dolichos biflorus)</deviceName>
    <manufacturerName>ANTITOXIN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008156</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030399</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY  (BLOOD GROUPING) TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04.235-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:40:31.757Z</lastUpdated>
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    <udiDi>03770029504090</udiDi>
    <basicUdiDi>B-03770029504090</basicUdiDi>
    <tradeName>AIO-RHD FETAL DNA KIT</tradeName>
    <deviceName>AIO-RHD FETAL DNA KIT (150)</deviceName>
    <manufacturerName>GENOTROPY</manufacturerName>
    <manufacturerSrn>FR-MF-000026152</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030201</emdnCode>
    <emdnDescription>RHESUS D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GNPY #010-004</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:34:35.524Z</lastUpdated>
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    <udiDi>03770029504083</udiDi>
    <basicUdiDi>B-03770029504083</basicUdiDi>
    <tradeName>AIO-RHD FETAL DNA KIT</tradeName>
    <deviceName>AIO-RHD FETAL DNA KIT (300)</deviceName>
    <manufacturerName>GENOTROPY</manufacturerName>
    <manufacturerSrn>FR-MF-000026152</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030201</emdnCode>
    <emdnDescription>RHESUS D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GNPY #010-005</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:34:34.722Z</lastUpdated>
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    <udiDi>03770029504076</udiDi>
    <basicUdiDi>B-03770029504076</basicUdiDi>
    <tradeName>AIO-RHD FETAL DNA KIT</tradeName>
    <deviceName>AIO-RHD FETAL DNA KIT (450)</deviceName>
    <manufacturerName>GENOTROPY</manufacturerName>
    <manufacturerSrn>FR-MF-000026152</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030201</emdnCode>
    <emdnDescription>RHESUS D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GNPY #010-006</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:34:33.121Z</lastUpdated>
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</eudamedExport>