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<eudamedExport entity="devices">
  <row>
    <udiDi>D-IM4408301JR</udiDi>
    <basicUdiDi>B-IM4408301JR</basicUdiDi>
    <tradeName>D-IM4408301JR</tradeName>
    <deviceName>PCT (CLIA)</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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4408301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:30:20.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4407301JJ</udiDi>
    <basicUdiDi>B-IM4407301JJ</basicUdiDi>
    <tradeName>D-IM4407301JJ</tradeName>
    <deviceName>PCT (CLIA)</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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:29:23.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4407128JU</udiDi>
    <basicUdiDi>B-IM4407128JU</basicUdiDi>
    <tradeName>D-IM4407128JU</tradeName>
    <deviceName>Pepsinogen II Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407128</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:28:31.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4407127JS</udiDi>
    <basicUdiDi>B-IM4407127JS</basicUdiDi>
    <tradeName>D-IM4407127JS</tradeName>
    <deviceName>Pepsinogen I Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407127</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:28:29.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4406301JB</udiDi>
    <basicUdiDi>B-IM4406301JB</basicUdiDi>
    <tradeName>D-IM4406301JB</tradeName>
    <deviceName>PCT (CLIA)</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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:27:21.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4406128JM</udiDi>
    <basicUdiDi>B-IM4406128JM</basicUdiDi>
    <tradeName>D-IM4406128JM</tradeName>
    <deviceName>Pepsinogen II Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406128</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:26:26.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4406127JK</udiDi>
    <basicUdiDi>B-IM4406127JK</basicUdiDi>
    <tradeName>D-IM4406127JK</tradeName>
    <deviceName>Pepsinogen I Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406127</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:26:25.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4405301J4</udiDi>
    <basicUdiDi>B-IM4405301J4</basicUdiDi>
    <tradeName>D-IM4405301J4</tradeName>
    <deviceName>PCT (CLIA)</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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4405301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:25:16.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4404301HV</udiDi>
    <basicUdiDi>B-IM4404301HV</basicUdiDi>
    <tradeName>D-IM4404301HV</tradeName>
    <deviceName>PCT (CLIA)</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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4404301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:24:17.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4403301HN</udiDi>
    <basicUdiDi>B-IM4403301HN</basicUdiDi>
    <tradeName>D-IM4403301HN</tradeName>
    <deviceName>PCT (CLIA)</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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:23:12.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4403128HY</udiDi>
    <basicUdiDi>B-IM4403128HY</basicUdiDi>
    <tradeName>D-IM4403128HY</tradeName>
    <deviceName>Pepsinogen II Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403128</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:22:13.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4403127HW</udiDi>
    <basicUdiDi>B-IM4403127HW</basicUdiDi>
    <tradeName>D-IM4403127HW</tradeName>
    <deviceName>Pepsinogen I Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403127</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:22:09.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4402301HF</udiDi>
    <basicUdiDi>B-IM4402301HF</basicUdiDi>
    <tradeName>D-IM4402301HF</tradeName>
    <deviceName>PCT (CLIA)</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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:18:49.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4402128HR</udiDi>
    <basicUdiDi>B-IM4402128HR</basicUdiDi>
    <tradeName>D-IM4402128HR</tradeName>
    <deviceName>Pepsinogen II Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402128</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:17:49.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4402127HP</udiDi>
    <basicUdiDi>B-IM4402127HP</basicUdiDi>
    <tradeName>D-IM4402127HP</tradeName>
    <deviceName>Pepsinogen I Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402127</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:17:48.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4401301H8</udiDi>
    <basicUdiDi>B-IM4401301H8</basicUdiDi>
    <tradeName>D-IM4401301H8</tradeName>
    <deviceName>PCT (CLIA)</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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4401301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:16:36.203Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD179Y5</udiDi>
    <basicUdiDi>B-GKPD179Y5</basicUdiDi>
    <tradeName>PGII Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>PGII Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD179</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:39:34.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD178Y3</udiDi>
    <basicUdiDi>B-GKPD178Y3</basicUdiDi>
    <tradeName>PGI Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>PGI Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD178</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:39:33.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD177XZ</udiDi>
    <basicUdiDi>B-GKPD177XZ</basicUdiDi>
    <tradeName>PGI / PGII Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>PGI / PGII Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD177</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:39:29.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD176XX</udiDi>
    <basicUdiDi>B-GKPD176XX</basicUdiDi>
    <tradeName>Gastrin-17 Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>Gastrin-17 Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069001</emdnCode>
    <emdnDescription>GASTRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD176</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:39:28.792Z</lastUpdated>
  </row>
</eudamedExport>