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<eudamedExport entity="devices">
  <row>
    <udiDi>D-IM4403251HY</udiDi>
    <basicUdiDi>B-IM4403251HY</basicUdiDi>
    <tradeName>D-IM4403251HY</tradeName>
    <deviceName>Anti-CCP Chemiluminescent Immunoassay Kit</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>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403251</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:22:47.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4402251HR</udiDi>
    <basicUdiDi>B-IM4402251HR</basicUdiDi>
    <tradeName>D-IM4402251HR</tradeName>
    <deviceName>Anti-CCP Chemiluminescent Immunoassay Kit</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>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402251</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:18:37.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4401251HJ</udiDi>
    <basicUdiDi>B-IM4401251HJ</basicUdiDi>
    <tradeName>D-IM4401251HJ</tradeName>
    <deviceName>Anti-CCP Chemiluminescent Immunoassay Kit</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>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4401251</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:16:35.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76368GC</udiDi>
    <basicUdiDi>B-DC76368GC</basicUdiDi>
    <tradeName>iStar-Anti-CCP</tradeName>
    <deviceName>iStar-Anti-CCP</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>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76368</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:13:15.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76367GA</udiDi>
    <basicUdiDi>B-DC76367GA</basicUdiDi>
    <tradeName>iStar-Anti-CCP</tradeName>
    <deviceName>iStar-Anti-CCP</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>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76368</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:13:14.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76366G8</udiDi>
    <basicUdiDi>B-DC76366G8</basicUdiDi>
    <tradeName>iStar-Anti-CCP</tradeName>
    <deviceName>iStar-Anti-CCP</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>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76366</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:13:13.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76365G6</udiDi>
    <basicUdiDi>B-DC76365G6</basicUdiDi>
    <tradeName>iStar-Anti-CCP</tradeName>
    <deviceName>iStar-Anti-CCP</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>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76365</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:13:09.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76063FK</udiDi>
    <basicUdiDi>B-DC76063FK</basicUdiDi>
    <tradeName>iStar-Anti-CCP</tradeName>
    <deviceName>iStar-Anti-CCP</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76063</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:48.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ACCP706-AEKR</udiDi>
    <basicUdiDi>B-ACCP706-AEKR</basicUdiDi>
    <tradeName>Anti-CCP Anti-Cyclic Citrullinated Peptides Antibody (CLIA)</tradeName>
    <deviceName>Anti-CCP Anti-Cyclic Citrullinated Peptides Antibody (CLIA)</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>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACCP706-AE10Y, ACCP706-AE10N, ACCP706-AE20Y, ACCP706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:01.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147196738</udiDi>
    <basicUdiDi>B-86060147196738</basicUdiDi>
    <tradeName>CCP IgG</tradeName>
    <deviceName>CCP IgG</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N702A24IGG</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:32.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7M26FE</udiDi>
    <basicUdiDi>B-7M26FE</basicUdiDi>
    <tradeName>Anti-CCP assay (CLIA)</tradeName>
    <deviceName>Anti-CCP assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7M26V1-B-EU, 7M26U1-B-EU, 7M26P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:28:59.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912723233</udiDi>
    <basicUdiDi>692591270044H5</basicUdiDi>
    <tradeName>iFlash-Anti-CCP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C89017G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:09.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763693</udiDi>
    <basicUdiDi>B-15065023763693</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>Anti-CCP Test (FIA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV20031</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:36:14.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-11C7G</udiDi>
    <basicUdiDi>B-11C7G</basicUdiDi>
    <tradeName>D-11C7G</tradeName>
    <deviceName>Anti-Cyclic Citrullinated Peptide Antibody Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:16.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548255426</udiDi>
    <basicUdiDi>B-08683548255426</basicUdiDi>
    <tradeName>RapidFor™ Anti-CCP Plus Rapid Test Kit (FIA)</tradeName>
    <deviceName>Anti-CCP Plus Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO77</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:14:36.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435287148602</udiDi>
    <basicUdiDi>B-08435287148602</basicUdiDi>
    <tradeName>08435287148602</tradeName>
    <deviceName>ANTI-CITRULLINATED PROTEIN ANTIBODIES (ACPA)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>44860</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:50:58.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950448358</udiDi>
    <basicUdiDi>B-08426950448358</basicUdiDi>
    <tradeName>QUANTA Lite</tradeName>
    <deviceName>QUANTA Lite® CCP3 IgG ELISA</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>704535</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:18:26.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979878281160</udiDi>
    <basicUdiDi>B-06979878281160</basicUdiDi>
    <tradeName>06979878281160</tradeName>
    <deviceName>Anti-CCP Test (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Huzhou Jierunxin Biotechnology Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000047637</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001014</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:50:23.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979469761057</udiDi>
    <basicUdiDi>B-06979469761057</basicUdiDi>
    <tradeName>Anti-Cyclic Citrullinated Peptide Antibody (Anti-CCP) Test Kit</tradeName>
    <deviceName>Anti-Cyclic Citrullinated Peptide Antibody (Anti-CCP) Test Kit</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P1403CC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:42:35.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979469761040</udiDi>
    <basicUdiDi>B-06979469761040</basicUdiDi>
    <tradeName>Anti-Cyclic Citrullinated Peptide Antibody (Anti-CCP) Test Kit</tradeName>
    <deviceName>Anti-Cyclic Citrullinated Peptide Antibody (Anti-CCP) Test Kit</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P1404CC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:42:34.523Z</lastUpdated>
  </row>
</eudamedExport>