<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-EIM4281006GZ</udiDi>
    <basicUdiDi>B-EIM4281006GZ</basicUdiDi>
    <tradeName>D-EIM4281006GZ</tradeName>
    <deviceName>Progesterone Calibrators</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>W0102152202</emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4281006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:53:37.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4281005GX</udiDi>
    <basicUdiDi>B-EIM4281005GX</basicUdiDi>
    <tradeName>D-EIM4281005GX</tradeName>
    <deviceName>PRL Calibrators</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>W0102152202</emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4281005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:53:36.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4281004GV</udiDi>
    <basicUdiDi>B-EIM4281004GV</basicUdiDi>
    <tradeName>D-EIM4281004GV</tradeName>
    <deviceName>LH Calibrators</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>W0102152202</emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4281004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:53:32.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4281003GT</udiDi>
    <basicUdiDi>B-EIM4281003GT</basicUdiDi>
    <tradeName>D-EIM4281003GT</tradeName>
    <deviceName>FSH Calibrators</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>W0102152202</emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4281003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:53:31.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4281002GR</udiDi>
    <basicUdiDi>B-EIM4281002GR</basicUdiDi>
    <tradeName>D-EIM4281002GR</tradeName>
    <deviceName>free β-HCG Calibrators</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>W0102152202</emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4281002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:53:30.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4281001GP</udiDi>
    <basicUdiDi>B-EIM4281001GP</basicUdiDi>
    <tradeName>D-EIM4281001GP</tradeName>
    <deviceName>HCG Calibrators</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>W0102152202</emdnCode>
    <emdnDescription>HORMONE STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4281001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:53:29.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01833037W</udiDi>
    <basicUdiDi>B-ECH01833037W</basicUdiDi>
    <tradeName>D-ECH01833037W</tradeName>
    <deviceName>C-reactive protein (CRP) Calibrator</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>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0183303</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:38.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01833017S</udiDi>
    <basicUdiDi>B-ECH01833017S</basicUdiDi>
    <tradeName>D-ECH01833017S</tradeName>
    <deviceName>Anti-Streptolysin O (ASO) Calibrator</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>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0183301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:34.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01823037P</udiDi>
    <basicUdiDi>B-ECH01823037P</basicUdiDi>
    <tradeName>D-ECH01823037P</tradeName>
    <deviceName>C-reactive protein (CRP) Calibrator</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>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0182303</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:26.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01822117H</udiDi>
    <basicUdiDi>B-ECH01822117H</basicUdiDi>
    <tradeName>D-ECH01822117H</tradeName>
    <deviceName>CK &amp; CK-MB Calibrator</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>W0102152204</emdnCode>
    <emdnDescription>CARDIAC MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0182211</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:21.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01823017K</udiDi>
    <basicUdiDi>B-ECH01823017K</basicUdiDi>
    <tradeName>D-ECH01823017K</tradeName>
    <deviceName>Anti-Streptolysin O (ASO) Calibrator</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>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0182301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:09.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01813037G</udiDi>
    <basicUdiDi>B-ECH01813037G</basicUdiDi>
    <tradeName>D-ECH01813037G</tradeName>
    <deviceName>C-reactive protein (CRP) Calibrator</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>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0181303</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:38:47.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01813017C</udiDi>
    <basicUdiDi>B-ECH01813017C</basicUdiDi>
    <tradeName>D-ECH01813017C</tradeName>
    <deviceName>Anti-Streptolysin O (ASO) Calibrator</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>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0181301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:38:45.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01812117A</udiDi>
    <basicUdiDi>B-ECH01812117A</basicUdiDi>
    <tradeName>D-ECH01812117A</tradeName>
    <deviceName>CK &amp; CK-MB Calibrator</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>W0102152204</emdnCode>
    <emdnDescription>CARDIAC MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0181211</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:38:42.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CJZ-K-2486-MNR</udiDi>
    <basicUdiDi>B-CJZ-K-2486-MNR</basicUdiDi>
    <tradeName>D-CJZ-K-2486-MNR</tradeName>
    <deviceName>Human anti-salivary gland protein I antibody CLlA Kit (IgM)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152211</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJZ-K-2486-M</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:10.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CJZ-K-2486-AMZ</udiDi>
    <basicUdiDi>B-CJZ-K-2486-AMZ</basicUdiDi>
    <tradeName>D-CJZ-K-2486-AMZ</tradeName>
    <deviceName>Human anti-salivary gland protein I antibody CLlA Kit (IgA)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152211</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJZ-K-2486-A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:03.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CJZ-K-2486-GND</udiDi>
    <basicUdiDi>B-CJZ-K-2486-GND</basicUdiDi>
    <tradeName>D-CJZ-K-2486-GND</tradeName>
    <deviceName>Human anti-salivary gland protein I antibody CLlA Kit (IgG)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152211</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJZ-K-2486-G</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:02.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CJZ-K-2485-MNL</udiDi>
    <basicUdiDi>B-CJZ-K-2485-MNL</basicUdiDi>
    <tradeName>D-CJZ-K-2485-MNL</tradeName>
    <deviceName>Human anti-CA6 antibody CLIA Kit (IgM)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152211</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJZ-K-2485-M</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:05:49.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CJZ-K-2485-GN8</udiDi>
    <basicUdiDi>B-CJZ-K-2485-GN8</basicUdiDi>
    <tradeName>D-CJZ-K-2485-GN8</tradeName>
    <deviceName>Human anti-CA6 antibody CLIA Kit (IgG)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152211</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJZ-K-2485-G</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:05:47.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CJZ-K-2485-AMU</udiDi>
    <basicUdiDi>B-CJZ-K-2485-AMU</basicUdiDi>
    <tradeName>D-CJZ-K-2485-AMU</tradeName>
    <deviceName>Human anti-CA6 antibody CLIA Kit (IgA)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152211</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJZ-K-2485-A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:05:45.256Z</lastUpdated>
  </row>
</eudamedExport>