<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ECH01982189L</udiDi>
    <basicUdiDi>B-ECH01982189L</basicUdiDi>
    <tradeName>D-ECH01982189L</tradeName>
    <deviceName>5′-Nucleotidase (5'-NT) Control</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>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0198218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:38.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01972189D</udiDi>
    <basicUdiDi>B-ECH01972189D</basicUdiDi>
    <tradeName>D-ECH01972189D</tradeName>
    <deviceName>5′-Nucleotidase (5'-NT) Control</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>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0197218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:37.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH019621896</udiDi>
    <basicUdiDi>B-ECH019621896</basicUdiDi>
    <tradeName>D-ECH019621896</tradeName>
    <deviceName>5′-Nucleotidase (5'-NT) Control</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>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0196218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:32.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01961048N</udiDi>
    <basicUdiDi>B-ECH01961048N</basicUdiDi>
    <tradeName>D-ECH01961048N</tradeName>
    <deviceName>Glycosylated Hemoglobin A1c (HbA1c) Control</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>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0196104</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:31.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH019605694</udiDi>
    <basicUdiDi>B-ECH019605694</basicUdiDi>
    <tradeName>D-ECH019605694</tradeName>
    <deviceName>Cystatin C (Cys C) Control</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0196056</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:30.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH019535192</udiDi>
    <basicUdiDi>B-ECH019535192</basicUdiDi>
    <tradeName>D-ECH019535192</tradeName>
    <deviceName>Homocysteine (Hcy) Control</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0195351</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:25.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01952188X</udiDi>
    <basicUdiDi>B-ECH01952188X</basicUdiDi>
    <tradeName>D-ECH01952188X</tradeName>
    <deviceName>5′-Nucleotidase (5'-NT) Control</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>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0195218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:25.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01951048F</udiDi>
    <basicUdiDi>B-ECH01951048F</basicUdiDi>
    <tradeName>D-ECH01951048F</tradeName>
    <deviceName>Glycosylated Hemoglobin A1c (HbA1c) Control</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>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0195104</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:23.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01950608L</udiDi>
    <basicUdiDi>B-ECH01950608L</basicUdiDi>
    <tradeName>D-ECH01950608L</tradeName>
    <deviceName>Urinary Microalbumin (mAlb) Control</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0195060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:19.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01950568V</udiDi>
    <basicUdiDi>B-ECH01950568V</basicUdiDi>
    <tradeName>D-ECH01950568V</tradeName>
    <deviceName>Cystatin C (Cys C) Control</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0195056</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:18.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01942188Q</udiDi>
    <basicUdiDi>B-ECH01942188Q</basicUdiDi>
    <tradeName>D-ECH01942188Q</tradeName>
    <deviceName>5′-Nucleotidase (5'-NT) Control</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>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0194218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:17.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH019410488</udiDi>
    <basicUdiDi>B-ECH019410488</basicUdiDi>
    <tradeName>D-ECH019410488</tradeName>
    <deviceName>Glycosylated Hemoglobin A1c (HbA1c) Control</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>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0194104</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:12.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01940628H</udiDi>
    <basicUdiDi>B-ECH01940628H</basicUdiDi>
    <tradeName>D-ECH01940628H</tradeName>
    <deviceName>α1-Microglobulin (α1-MG) Control</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0194062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:11.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01940618F</udiDi>
    <basicUdiDi>B-ECH01940618F</basicUdiDi>
    <tradeName>D-ECH01940618F</tradeName>
    <deviceName>Neutrophil Gelatinase-associated Lipocalin (NGAL) Control</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0194061</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:10.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01940608D</udiDi>
    <basicUdiDi>B-ECH01940608D</basicUdiDi>
    <tradeName>D-ECH01940608D</tradeName>
    <deviceName>Urinary Microalbumin (mAlb) Control</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0194060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:06.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH019400585</udiDi>
    <basicUdiDi>B-ECH019400585</basicUdiDi>
    <tradeName>D-ECH019400585</tradeName>
    <deviceName>Total Bile Acids (TBA) Control</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0194005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:06.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01932188H</udiDi>
    <basicUdiDi>B-ECH01932188H</basicUdiDi>
    <tradeName>D-ECH01932188H</tradeName>
    <deviceName>5′-Nucleotidase (5'-NT) Control</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>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0193218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:42:04.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH019320588</udiDi>
    <basicUdiDi>B-ECH019320588</basicUdiDi>
    <tradeName>D-ECH019320588</tradeName>
    <deviceName>α-L-Fucosidase (AFU) Control</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>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0193205</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:40:43.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01931047Z</udiDi>
    <basicUdiDi>B-ECH01931047Z</basicUdiDi>
    <tradeName>D-ECH01931047Z</tradeName>
    <deviceName>Glycosylated Hemoglobin A1c (HbA1c) Control</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>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0193104</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:40:42.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01930628A</udiDi>
    <basicUdiDi>B-ECH01930628A</basicUdiDi>
    <tradeName>D-ECH01930628A</tradeName>
    <deviceName>α1-Microglobulin (α1-MG) Control</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0193062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:40:41.414Z</lastUpdated>
  </row>
</eudamedExport>