<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-FA0015Z5</udiDi>
    <basicUdiDi>B-FA0015Z5</basicUdiDi>
    <tradeName>High Sensitive C-Reactive Protein (hs-CRP) Test Kit(Immunofluorescence)</tradeName>
    <deviceName>High Sensitive C-Reactive Protein (hs-CRP) Test Kit(Immunofluorescence)</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>52027010</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:15:42.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4103076EX</udiDi>
    <basicUdiDi>B-EIM4103076EX</basicUdiDi>
    <tradeName>D-EIM4103076EX</tradeName>
    <deviceName>high sensitive C-reactive protein (hs-CRP) Assay Kit by Fluorescence Immunochromatographic Method</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4103076</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:47:36.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4102076EQ</udiDi>
    <basicUdiDi>B-EIM4102076EQ</basicUdiDi>
    <tradeName>D-EIM4102076EQ</tradeName>
    <deviceName>high sensitive C-reactive protein (hs-CRP) Assay Kit by Fluorescence Immunochromatographic Method</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4102076</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:47:32.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4101076EH</udiDi>
    <basicUdiDi>B-EIM4101076EH</basicUdiDi>
    <tradeName>D-EIM4101076EH</tradeName>
    <deviceName>high sensitive C-reactive protein (hs-CRP) Assay Kit by Fluorescence Immunochromatographic Method</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4101076</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:47:22.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01063115S</udiDi>
    <basicUdiDi>B-ECH01063115S</basicUdiDi>
    <tradeName>D-ECH01063115S</tradeName>
    <deviceName>high sensitivity C-reactive protein  (hs-CRP)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0106311</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:37:48.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01053115K</udiDi>
    <basicUdiDi>B-ECH01053115K</basicUdiDi>
    <tradeName>D-ECH01053115K</tradeName>
    <deviceName>high sensitivity C-reactive protein  (hs-CRP)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0105311</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:37:18.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH010331155</udiDi>
    <basicUdiDi>B-ECH010331155</basicUdiDi>
    <tradeName>D-ECH010331155</tradeName>
    <deviceName>high sensitivity C-reactive protein  (hs-CRP)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0103311</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:35:39.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01013114P</udiDi>
    <basicUdiDi>B-ECH01013114P</basicUdiDi>
    <tradeName>D-ECH01013114P</tradeName>
    <deviceName>high sensitivity C-reactive protein  (hs-CRP)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101311</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:34:46.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT0166-B2R</udiDi>
    <basicUdiDi>B-DT0166-B2R</basicUdiDi>
    <tradeName>CRP</tradeName>
    <deviceName>CRP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0166-B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:17:20.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT0166-A2P</udiDi>
    <basicUdiDi>B-DT0166-A2P</basicUdiDi>
    <tradeName>CRP</tradeName>
    <deviceName>CRP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0166-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:17:19.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT0165-B2L</udiDi>
    <basicUdiDi>B-DT0165-B2L</basicUdiDi>
    <tradeName>CRP</tradeName>
    <deviceName>CRP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0166-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:17:16.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT0165-A2J</udiDi>
    <basicUdiDi>B-DT0165-A2J</basicUdiDi>
    <tradeName>CRP</tradeName>
    <deviceName>CRP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0165-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:17:15.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT0071-BZR</udiDi>
    <basicUdiDi>B-DT0071-BZR</basicUdiDi>
    <tradeName>Unicorn-CRP</tradeName>
    <deviceName>Unicorn-CRP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0071-B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:15:26.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT0071-AZP</udiDi>
    <basicUdiDi>B-DT0071-AZP</basicUdiDi>
    <tradeName>Unicorn-CRP</tradeName>
    <deviceName>Unicorn-CRP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0071-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:15:21.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT0007-BZ6</udiDi>
    <basicUdiDi>B-DT0007-BZ6</basicUdiDi>
    <tradeName>Unicorn-CRP</tradeName>
    <deviceName>Unicorn-CRP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0007-B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:14:14.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT0007-AZ4</udiDi>
    <basicUdiDi>B-DT0007-AZ4</basicUdiDi>
    <tradeName>Unicorn-CRP</tradeName>
    <deviceName>Unicorn-CRP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0007-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:14:13.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76252FQ</udiDi>
    <basicUdiDi>B-DC76252FQ</basicUdiDi>
    <tradeName>iStar-CRP</tradeName>
    <deviceName>iStar-CRP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76252</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:12:10.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76251FN</udiDi>
    <basicUdiDi>B-DC76251FN</basicUdiDi>
    <tradeName>iStar-CRP</tradeName>
    <deviceName>iStar-CRP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76251</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:12:09.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76250FL</udiDi>
    <basicUdiDi>B-DC76250FL</basicUdiDi>
    <tradeName>iStar-CRP</tradeName>
    <deviceName>iStar-CRP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76250</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:12:05.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76089G5</udiDi>
    <basicUdiDi>B-DC76089G5</basicUdiDi>
    <tradeName>iStar-CRP</tradeName>
    <deviceName>iStar-CRP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76089</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:04:24.964Z</lastUpdated>
  </row>
</eudamedExport>