<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ECH019306188</udiDi>
    <basicUdiDi>B-ECH019306188</basicUdiDi>
    <tradeName>D-ECH019306188</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>ECH0193061</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:40:40.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01930568F</udiDi>
    <basicUdiDi>B-ECH01930568F</basicUdiDi>
    <tradeName>D-ECH01930568F</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>ECH0193056</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:40:39.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01930057W</udiDi>
    <basicUdiDi>B-ECH01930057W</basicUdiDi>
    <tradeName>D-ECH01930057W</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>ECH0193005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:40:36.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01923518D</udiDi>
    <basicUdiDi>B-ECH01923518D</basicUdiDi>
    <tradeName>D-ECH01923518D</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>ECH0192351</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:40:29.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH019206283</udiDi>
    <basicUdiDi>B-ECH019206283</basicUdiDi>
    <tradeName>D-ECH019206283</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>ECH0192062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:40:21.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01920617Z</udiDi>
    <basicUdiDi>B-ECH01920617Z</basicUdiDi>
    <tradeName>D-ECH01920617Z</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>ECH0192061</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:40:06.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01920607X</udiDi>
    <basicUdiDi>B-ECH01920607X</basicUdiDi>
    <tradeName>D-ECH01920607X</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>ECH0192060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:40:05.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH019205688</udiDi>
    <basicUdiDi>B-ECH019205688</basicUdiDi>
    <tradeName>D-ECH019205688</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>ECH0192056</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:40:04.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01920057P</udiDi>
    <basicUdiDi>B-ECH01920057P</basicUdiDi>
    <tradeName>D-ECH01920057P</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>ECH0192005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:40:03.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01910627U</udiDi>
    <basicUdiDi>B-ECH01910627U</basicUdiDi>
    <tradeName>D-ECH01910627U</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>ECH0191062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:51.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01910617S</udiDi>
    <basicUdiDi>B-ECH01910617S</basicUdiDi>
    <tradeName>D-ECH01910617S</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>ECH0191061</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:50.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01910607Q</udiDi>
    <basicUdiDi>B-ECH01910607Q</basicUdiDi>
    <tradeName>D-ECH01910607Q</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>ECH0191060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:46.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CC02225BT</udiDi>
    <basicUdiDi>B-CC02225BT</basicUdiDi>
    <tradeName>ONE‐TROL 2</tradeName>
    <deviceName>ONE‐TROL 2</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONE‐TROL 2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:56:02.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CC02259CC</udiDi>
    <basicUdiDi>B-CC02259CC</basicUdiDi>
    <tradeName>Homocystein Control</tradeName>
    <deviceName>Homocystein Control</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC02259</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:55:59.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CC02226BV</udiDi>
    <basicUdiDi>B-CC02226BV</basicUdiDi>
    <tradeName>ONE‐TROL 3</tradeName>
    <deviceName>ONE‐TROL 3</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC02226</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:55:59.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-910101NW</udiDi>
    <basicUdiDi>B-910101NW</basicUdiDi>
    <tradeName>spinit®</tradeName>
    <deviceName>spinit® CRP control</deviceName>
    <manufacturerName>biosurfit SA</manufacturerName>
    <manufacturerSrn>PT-MF-000033920</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>910101</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:55:20.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897080206</udiDi>
    <basicUdiDi>B-87205897080206</basicUdiDi>
    <tradeName>Occult bloed in feces, Level High</tradeName>
    <deviceName>Faecal occult blood</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BLF-01.2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:22:03.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897080138</udiDi>
    <basicUdiDi>B-87205897080138</basicUdiDi>
    <tradeName>Occult bloed in feces, level Low</tradeName>
    <deviceName>Faecal occult blood</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BLF-01.1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:21:57.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4260152490630SX</udiDi>
    <basicUdiDi>B-4260152490630SX</basicUdiDi>
    <tradeName>Glucose Kontrolle</tradeName>
    <deviceName>Glucose Kontrolle</deviceName>
    <manufacturerName>Diaglobal GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032608</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLU QS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:18:21.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4260152490036SD</udiDi>
    <basicUdiDi>B-4260152490036SD</basicUdiDi>
    <tradeName>Lactat Kontroll Set</tradeName>
    <deviceName>DP 350 / DP 550</deviceName>
    <manufacturerName>Diaglobal GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032608</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAC QS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:17:30.966Z</lastUpdated>
  </row>
</eudamedExport>