<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DC76342FS</udiDi>
    <basicUdiDi>B-DC76342FS</basicUdiDi>
    <tradeName>iStar-Pepsinogen II</tradeName>
    <deviceName>iStar-Pepsinogen II</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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76342</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:12:30.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76341FQ</udiDi>
    <basicUdiDi>B-DC76341FQ</basicUdiDi>
    <tradeName>iStar-Pepsinogen I</tradeName>
    <deviceName>iStar-Pepsinogen I</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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76341</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:12:29.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76340FN</udiDi>
    <basicUdiDi>B-DC76340FN</basicUdiDi>
    <tradeName>iStar-Pepsinogen I</tradeName>
    <deviceName>iStar-Pepsinogen I</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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76340</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:12:28.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76339G5</udiDi>
    <basicUdiDi>B-DC76339G5</basicUdiDi>
    <tradeName>iStar-Pepsinogen I</tradeName>
    <deviceName>iStar-Pepsinogen I</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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76339</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:12:25.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76144FL</udiDi>
    <basicUdiDi>B-DC76144FL</basicUdiDi>
    <tradeName>iStar-PCT Ⅱ</tradeName>
    <deviceName>iStar-PCT Ⅱ</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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76144</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:06:16.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76143FJ</udiDi>
    <basicUdiDi>B-DC76143FJ</basicUdiDi>
    <tradeName>iStar-PCT Ⅱ</tradeName>
    <deviceName>iStar-PCT Ⅱ</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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76142</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:06:14.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76142FG</udiDi>
    <basicUdiDi>B-DC76142FG</basicUdiDi>
    <tradeName>iStar-PCT Ⅱ</tradeName>
    <deviceName>iStar-PCT Ⅱ</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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76142</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:06:11.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76141FE</udiDi>
    <basicUdiDi>B-DC76141FE</basicUdiDi>
    <tradeName>iStar-PCT Ⅱ</tradeName>
    <deviceName>iStar-PCT Ⅱ</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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76141</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:06:09.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76060FD</udiDi>
    <basicUdiDi>B-DC76060FD</basicUdiDi>
    <tradeName>iStar-Pepsinogen II</tradeName>
    <deviceName>iStar-Pepsinogen II</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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76060</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:43.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76059FU</udiDi>
    <basicUdiDi>B-DC76059FU</basicUdiDi>
    <tradeName>iStar-Pepsinogen I</tradeName>
    <deviceName>iStar-Pepsinogen I</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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76059</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:41.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76026FD</udiDi>
    <basicUdiDi>B-DC76026FD</basicUdiDi>
    <tradeName>iStar-Pepsinogen II</tradeName>
    <deviceName>iStar-Pepsinogen II</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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76026</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:07.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76025FB</udiDi>
    <basicUdiDi>B-DC76025FB</basicUdiDi>
    <tradeName>iStar-Pepsinogen I</tradeName>
    <deviceName>iStar-Pepsinogen I</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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76025</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:04.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76014F6</udiDi>
    <basicUdiDi>B-DC76014F6</basicUdiDi>
    <tradeName>iStar-PCT</tradeName>
    <deviceName>iStar-PCT</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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:02:40.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CN-MF-000013251RC</udiDi>
    <basicUdiDi>B-CN-MF-000013251RC</basicUdiDi>
    <tradeName>D-CN-MF-000013251RC</tradeName>
    <deviceName>PG I Reagent Kit</deviceName>
    <manufacturerName>Virtue Diagnostics (Suzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013251</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>12001008,12001048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:09:12.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AL-1572Y</udiDi>
    <basicUdiDi>B-AL-1572Y</basicUdiDi>
    <tradeName>D-AL-1572Y</tradeName>
    <deviceName>AL-157 Gucagon ELISA (CE)</deviceName>
    <manufacturerName>Ansh Labs</manufacturerName>
    <manufacturerSrn>US-MF-000054510</manufacturerSrn>
    <authorisedRepresentativeName>QNET B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002695</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069099</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AL-157</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:34:29.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313276158</udiDi>
    <basicUdiDi>B-86060313276158</basicUdiDi>
    <tradeName>PMN-Elastase</tradeName>
    <deviceName>PMN-Elastase</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>W0102069009</emdnCode>
    <emdnDescription>ELASTASE (PANCREATIC POLYPEPTIDE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1817ELA</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:15:18.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313274628</udiDi>
    <basicUdiDi>B-86060313274628</basicUdiDi>
    <tradeName>Pancreatic elastase</tradeName>
    <deviceName>Pancreatic elastase</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>W0102069009</emdnCode>
    <emdnDescription>ELASTASE (PANCREATIC POLYPEPTIDE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1825PELA</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:54.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7M17FD</udiDi>
    <basicUdiDi>B-7M17FD</basicUdiDi>
    <tradeName>Procalcitonin assay (CLIA)</tradeName>
    <deviceName>Procalcitonin 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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7M17V1-B-EU, 7M17U1-B-EU, 7M17P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:28:37.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7C18DV</udiDi>
    <basicUdiDi>B-7C18DV</basicUdiDi>
    <tradeName>Gastrin-17 assay (CLIA)</tradeName>
    <deviceName>Gastrin-17 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>W0102069001</emdnCode>
    <emdnDescription>GASTRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7C18V1-B-EU, 7C18U1-B-EU, 7C18P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:57.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7C17DT</udiDi>
    <basicUdiDi>B-7C17DT</basicUdiDi>
    <tradeName>Pepsinogen II assay (CLIA)</tradeName>
    <deviceName>Pepsinogen II 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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7C17V1-B-EU, 7C17U1-B-EU, 7C17P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:56.619Z</lastUpdated>
  </row>
</eudamedExport>