<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-667710RW</udiDi>
    <basicUdiDi>B-667710RW</basicUdiDi>
    <tradeName>Ultimate-D Bilirubin Control Level 1</tradeName>
    <deviceName>Ultimate-D Bilirubin Control Level 1</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050203</emdnCode>
    <emdnDescription>BILIRUBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>667710</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:47:07.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6327F</udiDi>
    <basicUdiDi>B-6327F</basicUdiDi>
    <tradeName>D-6327F</tradeName>
    <deviceName>Urinary Control</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050207</emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:41:04.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6297S</udiDi>
    <basicUdiDi>B-6297S</basicUdiDi>
    <tradeName>D-6297S</tradeName>
    <deviceName>Enzyme Multical Control</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:39:36.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6167H</udiDi>
    <basicUdiDi>B-6167H</basicUdiDi>
    <tradeName>D-6167H</tradeName>
    <deviceName>Lipid Quality Control</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050202</emdnCode>
    <emdnDescription>LIPID CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:18:35.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-209Y</udiDi>
    <basicUdiDi>B-6-209Y</basicUdiDi>
    <tradeName>D-6-209Y</tradeName>
    <deviceName>5'- Nucleotidase (5'-NT) quality control products</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</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>"REF: USCA00000705, USCA00000706"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:12:01.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-13A3</udiDi>
    <basicUdiDi>B-6-13A3</basicUdiDi>
    <tradeName>D-6-13A3</tradeName>
    <deviceName>Enzyme compound quality control products</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</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>"REF: USCA00000707, USCA00000708, USCA00000709, USCA00000710"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:09:05.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-138FR</udiDi>
    <basicUdiDi>B-6-138FR</basicUdiDi>
    <tradeName>D-6-138FR</tradeName>
    <deviceName>Homocysteine quality control material</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</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>REF: USCA00000764、USCA00000790-USCA00000797</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:09:04.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-137FP</udiDi>
    <basicUdiDi>B-6-137FP</basicUdiDi>
    <tradeName>D-6-137FP</tradeName>
    <deviceName>Creatine Kinase MB Isoenzymes (CK-MB) quality control products</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</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>"REF: USCA00000623 USCA00000783 USCA00000784 USCA00000785 USCA00000786 USCA00000787 USCA00000788 USCA00000789"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:09:01.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701700818915</udiDi>
    <basicUdiDi>37017008CKMB056K</basicUdiDi>
    <tradeName>CK-MB CONTROL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CKMB-1030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:21:18.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800037901392</udiDi>
    <basicUdiDi>B-08800037901392</basicUdiDi>
    <tradeName>08800037901392</tradeName>
    <deviceName>SimplexTAS CRP Control Level 2</deviceName>
    <manufacturerName>tascom co., ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000019000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0303002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:47:52.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800037901385</udiDi>
    <basicUdiDi>B-08800037901385</basicUdiDi>
    <tradeName>08800037901385</tradeName>
    <deviceName>SimplexTAS CRP Control Level 1</deviceName>
    <manufacturerName>tascom co., ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000019000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0303001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:47:50.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800037901378</udiDi>
    <basicUdiDi>B-08800037901378</basicUdiDi>
    <tradeName>08800037901378</tradeName>
    <deviceName>SimplexTAS HbA1c Control Level 2</deviceName>
    <manufacturerName>tascom co., ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000019000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0302002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:47:48.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800037901361</udiDi>
    <basicUdiDi>B-08800037901361</basicUdiDi>
    <tradeName>08800037901361</tradeName>
    <deviceName>SimplexTAS HbA1c Control Level 1</deviceName>
    <manufacturerName>tascom co., ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000019000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0302001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:47:48.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415168006897</udiDi>
    <basicUdiDi>B-05415168006897</basicUdiDi>
    <tradeName>HDL Cholesterol control +</tradeName>
    <deviceName>HDL Cholesterol control +</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050202</emdnCode>
    <emdnDescription>LIPID CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BIOPATH</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:50:42.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>05415168006880</udiDi>
    <basicUdiDi>B-05415168006880</basicUdiDi>
    <tradeName>HDL Cholesterol control -</tradeName>
    <deviceName>HDL Cholesterol control -</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050202</emdnCode>
    <emdnDescription>LIPID CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BIONORM</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:50:41.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883004610</udiDi>
    <basicUdiDi>B-00884883004610</basicUdiDi>
    <tradeName>00884883004610</tradeName>
    <deviceName>MAS Bilirubin Liquid Assayed Bilirubin Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050203</emdnCode>
    <emdnDescription>BILIRUBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10014430</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:35:56.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850011135051</udiDi>
    <basicUdiDi>B-00850011135051</basicUdiDi>
    <tradeName>VALIDATE® UC4 Test Set</tradeName>
    <deviceName>VALIDATE® UC4 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050207</emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>704bc</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:34:34.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URINARY-PROTEINS-CtrlFR</udiDi>
    <basicUdiDi>B-URINARY-PROTEINS-CtrlFR</basicUdiDi>
    <tradeName>URINARY PROTEINS CONTROL</tradeName>
    <deviceName>URINARY PROTEINS CONTROL</deviceName>
    <manufacturerName>FUTURLAB S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000046539</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050207</emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCC50-3-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:32:26.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCRSV-SDK</udiDi>
    <basicUdiDi>B-SCRSV-SDK</basicUdiDi>
    <tradeName>D-SCRSV-SDK</tradeName>
    <deviceName>RSV Control</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCRSV-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:40:30.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCROT-D-LTJ</udiDi>
    <basicUdiDi>B-SCROT-D-LTJ</basicUdiDi>
    <tradeName>D-SCROT-D-LTJ</tradeName>
    <deviceName>Rotavirus Control</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCROT-D-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:40:24.702Z</lastUpdated>
  </row>
</eudamedExport>