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<eudamedExport entity="devices">
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    <udiDi>06951110920143</udiDi>
    <basicUdiDi>695111092014C9</basicUdiDi>
    <tradeName>06951110920143</tradeName>
    <deviceName>Immunochromatography AI Reader</deviceName>
    <manufacturerName>Shenzhen Everbest Machinery lndustry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008730</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CV-200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:37:55.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996064866</udiDi>
    <basicUdiDi>69509960OG-H101MF</basicUdiDi>
    <tradeName>Mini Immunofluorescence Analyzer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OG-H101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:34:12.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996014731</udiDi>
    <basicUdiDi>69509960OG-G260CS9</basicUdiDi>
    <tradeName>Multi-channel Immunofluorescence Analyzer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OG-G260C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:33:24.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996003971</udiDi>
    <basicUdiDi>69509960OG-G260MV</basicUdiDi>
    <tradeName>Multiplex Fluorescent Analyzer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OG-G260</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:32:07.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002752</udiDi>
    <basicUdiDi>69509960OG-G300MG</basicUdiDi>
    <tradeName>Hand-Held Immunofluorescence Analyzer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OG-G300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:32:04.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002745</udiDi>
    <basicUdiDi>69509960OG-G200MB</basicUdiDi>
    <tradeName>Immunofluorescence Analyzer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OG-G200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:58.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002738</udiDi>
    <basicUdiDi>69509960OG-H100MD</basicUdiDi>
    <tradeName>Mini Immunofluorescence Analyzer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OG-H100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:57.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002684</udiDi>
    <basicUdiDi>69509960OG-H180N5</basicUdiDi>
    <tradeName>Immunofluorescence Analyzer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OG-H180</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:48.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>08445982000075</udiDi>
    <basicUdiDi>8445982Q1A-DUO-USBZM</basicUdiDi>
    <tradeName>Qassay Lateral Flow Reader DUAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>P4Q Health S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000039526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q1A-DUO-USB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:41:05.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>08445982000181</udiDi>
    <basicUdiDi>8445982Q1A-DUO-USBZM</basicUdiDi>
    <tradeName>08445982000181</tradeName>
    <deviceName></deviceName>
    <manufacturerName>P4Q Health S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000039526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q1A-DUO-USB-002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:41:05.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934822535577</udiDi>
    <basicUdiDi>693482255660JJ</basicUdiDi>
    <tradeName>06934822535577</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Compass2800-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:58:07.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934822535225</udiDi>
    <basicUdiDi>693482255902JK</basicUdiDi>
    <tradeName>06934822535225</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Compass3000-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:57:10.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934822535027</udiDi>
    <basicUdiDi>693482255600HY</basicUdiDi>
    <tradeName>06934822535027</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Compass2000-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T09:56:44.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987595300929</udiDi>
    <basicUdiDi>4987595PATHFASTSC</basicUdiDi>
    <tradeName>PATHFAST</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PHC Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008516</manufacturerSrn>
    <authorisedRepresentativeName>PHC Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002692</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300929</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:22.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987595300936</udiDi>
    <basicUdiDi>4987595PATHFASTSC</basicUdiDi>
    <tradeName>PATHFAST TIP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PHC Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008516</manufacturerSrn>
    <authorisedRepresentativeName>PHC Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002692</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300936</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:22.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987595300950</udiDi>
    <basicUdiDi>4987595PATHFASTSC</basicUdiDi>
    <tradeName>PATHFAST WASTE BOX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PHC Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008516</manufacturerSrn>
    <authorisedRepresentativeName>PHC Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002692</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300950</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:22.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111700064</udiDi>
    <basicUdiDi>88001117IPAA01FA02UK</basicUdiDi>
    <tradeName>STANDARD™ F200 Analyzer</tradeName>
    <deviceName></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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10FA20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:45.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111700071</udiDi>
    <basicUdiDi>88001117IPAA01FA02UK</basicUdiDi>
    <tradeName>STANDARD™ F200 Analyzer</tradeName>
    <deviceName></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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10FA20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:45.036Z</lastUpdated>
  </row>
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    <udiDi>08800111700125</udiDi>
    <basicUdiDi>88001117IPAA01FA03UM</basicUdiDi>
    <tradeName>STANDARD™ F2400 Analyzer</tradeName>
    <deviceName></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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10FA24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:44.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111700132</udiDi>
    <basicUdiDi>88001117IPAA01FA03UM</basicUdiDi>
    <tradeName>STANDARD™ F2400 Analyzer</tradeName>
    <deviceName></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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10FA24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:44.961Z</lastUpdated>
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