<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-IS02297NA</udiDi>
    <basicUdiDi>B-IS02297NA</basicUdiDi>
    <tradeName>β‐2 Microglobulin 4 levels Standard</tradeName>
    <deviceName>β‐2 Microglobulin 4 levels Standard</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS02297</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:42:07.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IS02267MZ</udiDi>
    <basicUdiDi>B-IS02267MZ</basicUdiDi>
    <tradeName>α‐1 Microglobulin Standard</tradeName>
    <deviceName>α‐1 Microglobulin Standard</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS02267</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:40:39.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01860558P</udiDi>
    <basicUdiDi>B-ECH01860558P</basicUdiDi>
    <tradeName>D-ECH01860558P</tradeName>
    <deviceName>β2-Microglobulin (β2-MG) 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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0186055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:46.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01850558G</udiDi>
    <basicUdiDi>B-ECH01850558G</basicUdiDi>
    <tradeName>D-ECH01850558G</tradeName>
    <deviceName>β2-Microglobulin (β2-MG) 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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0185055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:45.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH018405589</udiDi>
    <basicUdiDi>B-ECH018405589</basicUdiDi>
    <tradeName>D-ECH018405589</tradeName>
    <deviceName>β2-Microglobulin (β2-MG) 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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0184055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:40.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01833027U</udiDi>
    <basicUdiDi>B-ECH01833027U</basicUdiDi>
    <tradeName>D-ECH01833027U</tradeName>
    <deviceName>Rheumatoid Factor (RF) 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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0183302</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:38.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01832057V</udiDi>
    <basicUdiDi>B-ECH01832057V</basicUdiDi>
    <tradeName>D-ECH01832057V</tradeName>
    <deviceName>α-L-Fucosidase (AFU) 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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0183205</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:33.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01831047N</udiDi>
    <basicUdiDi>B-ECH01831047N</basicUdiDi>
    <tradeName>D-ECH01831047N</tradeName>
    <deviceName>Glycosylated Hemoglobin A1c (HbA1c) 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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0183104</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:32.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH018305582</udiDi>
    <basicUdiDi>B-ECH018305582</basicUdiDi>
    <tradeName>D-ECH018305582</tradeName>
    <deviceName>β2-Microglobulin (β2-MG) 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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0183055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:31.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01823117N</udiDi>
    <basicUdiDi>B-ECH01823117N</basicUdiDi>
    <tradeName>D-ECH01823117N</tradeName>
    <deviceName>High sensitivity C-reactive protein(hs-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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0182311</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:26.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01823027M</udiDi>
    <basicUdiDi>B-ECH01823027M</basicUdiDi>
    <tradeName>D-ECH01823027M</tradeName>
    <deviceName>Rheumatoid Factor (RF) 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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0182302</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:25.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01821047F</udiDi>
    <basicUdiDi>B-ECH01821047F</basicUdiDi>
    <tradeName>D-ECH01821047F</tradeName>
    <deviceName>Glycosylated Hemoglobin A1c (HbA1c) 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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0182104</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:38:53.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01820557T</udiDi>
    <basicUdiDi>B-ECH01820557T</basicUdiDi>
    <tradeName>D-ECH01820557T</tradeName>
    <deviceName>β2-Microglobulin (β2-MG) 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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0182055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:38:53.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01813117F</udiDi>
    <basicUdiDi>B-ECH01813117F</basicUdiDi>
    <tradeName>D-ECH01813117F</tradeName>
    <deviceName>High sensitivity C-reactive protein(hs-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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0181311</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:38:49.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01813027E</udiDi>
    <basicUdiDi>B-ECH01813027E</basicUdiDi>
    <tradeName>D-ECH01813027E</tradeName>
    <deviceName>Rheumatoid Factor (RF) 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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0181302</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:38:46.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01812067H</udiDi>
    <basicUdiDi>B-ECH01812067H</basicUdiDi>
    <tradeName>D-ECH01812067H</tradeName>
    <deviceName>Adenosine Deaminase (ADA) 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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0181206</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:38:41.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH018110478</udiDi>
    <basicUdiDi>B-ECH018110478</basicUdiDi>
    <tradeName>D-ECH018110478</tradeName>
    <deviceName>Glycosylated Hemoglobin A1c (HbA1c) 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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0181104</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:38:40.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01810557L</udiDi>
    <basicUdiDi>B-ECH01810557L</basicUdiDi>
    <tradeName>D-ECH01810557L</tradeName>
    <deviceName>β2-Microglobulin (β2-MG) 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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0181055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:38:38.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CS02967B</udiDi>
    <basicUdiDi>B-CS02967B</basicUdiDi>
    <tradeName>HDL/LDL Standard</tradeName>
    <deviceName>HDL/LDL Standard</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS0296</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:20:38.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CS02258JS</udiDi>
    <basicUdiDi>B-CS02258JS</basicUdiDi>
    <tradeName>Homocystein Standard</tradeName>
    <deviceName>Homocystein Standard</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS02258</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:20:34.493Z</lastUpdated>
  </row>
</eudamedExport>