<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-442772PZ</udiDi>
    <basicUdiDi>B-442772PZ</basicUdiDi>
    <tradeName>SYNCHRON® Systems Fe/IBCT Calibrator Kit</tradeName>
    <deviceName>SYNCHRON® Systems Fe/IBCT Calibrator Kit</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>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>442772</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:46:08.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-442600P3</udiDi>
    <basicUdiDi>B-442600P3</basicUdiDi>
    <tradeName>SYNCHRON® Systems SYNCHRON Multi Calibrator</tradeName>
    <deviceName>SYNCHRON® Systems SYNCHRON Multi Calibrator</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>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>442600</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:45:34.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-441350NU</udiDi>
    <basicUdiDi>B-441350NU</basicUdiDi>
    <tradeName>SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2</tradeName>
    <deviceName>SYNCHRON® Systems Enzyme Validator Set Levels 1 and 2</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>W0101050303</emdnCode>
    <emdnDescription>AQUEOUS STANDARDS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>441350</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:45:29.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>42625753901464</udiDi>
    <basicUdiDi>B-42625753901464</basicUdiDi>
    <tradeName>Z-Hb Confirm HbA1c Calibrator kit</tradeName>
    <deviceName>Z-Hb Confirm HbA1c Calibrator Kit</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</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>Z-RHBCA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:42:50.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>42625753901600</udiDi>
    <basicUdiDi>B-42625753901600</basicUdiDi>
    <tradeName>Z-Hb Confirm HbA1c Control Kit</tradeName>
    <deviceName>Z-Hb Confirm HbA1c Control Kit</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-RHBQC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:42:48.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>42625753900610</udiDi>
    <basicUdiDi>B-42625753900610</basicUdiDi>
    <tradeName>Trilevel Quality Controls (For Z-Elite Pro+)</tradeName>
    <deviceName>Trilevel Quality Controls (For Z-Elite Pro+)</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZA-EC6-P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:42:25.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>42625753900306</udiDi>
    <basicUdiDi>B-42625753900306</basicUdiDi>
    <tradeName>Quality Control Kit</tradeName>
    <deviceName>Quality Control Kit</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZA-EC2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:42:23.193Z</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-4260152490180SM</udiDi>
    <basicUdiDi>B-4260152490180SM</basicUdiDi>
    <tradeName>Bilirubin Kontrolle</tradeName>
    <deviceName>DP 550</deviceName>
    <manufacturerName>Diaglobal GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032608</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050203</emdnCode>
    <emdnDescription>BILIRUBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BIL QS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:17:46.188Z</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>
  <row>
    <udiDi>D-267.000.005EB</udiDi>
    <basicUdiDi>B-267.000.005EB</basicUdiDi>
    <tradeName>Eurotrol epoc Calibration Verification Fluids</tradeName>
    <deviceName>Eurotrol epoc Calibration Verification Fluids</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>267.000.005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:48:21.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-266.006.010FF</udiDi>
    <basicUdiDi>B-266.006.010FF</basicUdiDi>
    <tradeName>Eurotrol epoc GAS-ISE Metabolites Level 6</tradeName>
    <deviceName>Eurotrol epoc GAS-ISE Metabolites Level 6</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>266.006.010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:48:18.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-266.003.010EE</udiDi>
    <basicUdiDi>B-266.003.010EE</basicUdiDi>
    <tradeName>Eurotrol epoc GAS-ISE Metabolites Level 3</tradeName>
    <deviceName>Eurotrol epoc GAS-ISE Metabolites Level 3</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>266.003.010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:48:16.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-266.002.010E3</udiDi>
    <basicUdiDi>B-266.002.010E3</basicUdiDi>
    <tradeName>Eurotrol epoc GAS-ISE Metabolites Level 2</tradeName>
    <deviceName>Eurotrol epoc GAS-ISE Metabolites Level 2</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>266.002.010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:48:14.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-266.001.010DQ</udiDi>
    <basicUdiDi>B-266.001.010DQ</basicUdiDi>
    <tradeName>Eurotrol epoc GAS-ISE Metabolites Level 1</tradeName>
    <deviceName>Eurotrol epoc GAS-ISE Metabolites Level 1</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>266.001.010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:48:13.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-195.004.010FS</udiDi>
    <basicUdiDi>B-195.004.010FS</basicUdiDi>
    <tradeName>Hct Control Level B</tradeName>
    <deviceName>Hct Control Level B</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</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>195.004.010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:16:37.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-195.003.010FF</udiDi>
    <basicUdiDi>B-195.003.010FF</basicUdiDi>
    <tradeName>Hct Control Level C</tradeName>
    <deviceName>Hct Control Level C</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</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>195.003.010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:16:36.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-195.002.010F4</udiDi>
    <basicUdiDi>B-195.002.010F4</basicUdiDi>
    <tradeName>Hct Control Level A</tradeName>
    <deviceName>Hct Control Level A</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</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>195.002.010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:16:35.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-190.000.005B2</udiDi>
    <basicUdiDi>B-190.000.005B2</basicUdiDi>
    <tradeName>epoc Hematocrit Verification Fluids</tradeName>
    <deviceName>epoc Hematocrit Verification Fluids</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</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>190.000.005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:16:24.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-185.001.002DV</udiDi>
    <basicUdiDi>B-185.001.002DV</basicUdiDi>
    <tradeName>GlucoTrol-NG Level 1</tradeName>
    <deviceName>GlucoTrol-NG Level 1</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</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>185.001.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:28:14.015Z</lastUpdated>
  </row>
</eudamedExport>