<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-4260152490128SK</udiDi>
    <basicUdiDi>B-4260152490128SK</basicUdiDi>
    <tradeName>Hämoglobin</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>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB 342</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:17:39.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4260152490111S2</udiDi>
    <basicUdiDi>B-4260152490111S2</basicUdiDi>
    <tradeName>Hämoglobin</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>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB 142</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:17:38.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4260152490104S5</udiDi>
    <basicUdiDi>B-4260152490104S5</basicUdiDi>
    <tradeName>Hämatokrit</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>W0103010603</emdnCode>
    <emdnDescription>HAEMATOCRIT (HCT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCT 142</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:17:38.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4260152490081SJ</udiDi>
    <basicUdiDi>B-4260152490081SJ</basicUdiDi>
    <tradeName>Erythrocyten</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>W0103010602</emdnCode>
    <emdnDescription>ERYTHROCYTES (ERY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ERY 142</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:17:37.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-42601521910455</udiDi>
    <basicUdiDi>B-42601521910455</basicUdiDi>
    <tradeName>Hämatokrit</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>W0103010603</emdnCode>
    <emdnDescription>HAEMATOCRIT (HCT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCT 142</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:17:26.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-202.003.00265</udiDi>
    <basicUdiDi>B-202.003.00265</basicUdiDi>
    <tradeName>HemoTrol High (Level 3)</tradeName>
    <deviceName>HemoTrol High (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>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>202.003.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:27:57.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-202.002.0025S</udiDi>
    <basicUdiDi>B-202.002.0025S</basicUdiDi>
    <tradeName>HemoTrol Normal (Level 2)</tradeName>
    <deviceName>HemoTrol Normal (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>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>202.002.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:27:53.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-202.001.0025F</udiDi>
    <basicUdiDi>B-202.001.0025F</basicUdiDi>
    <tradeName>HemoTrol Low (Level 1)</tradeName>
    <deviceName>HemoTrol Low (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>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>202.001.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:27:52.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2-76K</udiDi>
    <basicUdiDi>B-2-76K</basicUdiDi>
    <tradeName>Reticulocyte Calibrator</tradeName>
    <deviceName>Reticulocyte Calibrator</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>W0103010607</emdnCode>
    <emdnDescription>HAEMATOLOGY STANDARDS AND CALIBRATORS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>USBH00002292</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:26:37.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2-1499</udiDi>
    <basicUdiDi>B-2-1499</basicUdiDi>
    <tradeName>HQ-CAL HEMATOLOGY CALIBRATOR</tradeName>
    <deviceName>HQ-CAL HEMATOLOGY CALIBRATOR</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>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:26:26.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2-1397</udiDi>
    <basicUdiDi>B-2-1397</basicUdiDi>
    <tradeName>HQ-6D HEMATOLOGY CONTROLS</tradeName>
    <deviceName>HQ-6D HEMATOLOGY CONTROLS</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>W0103010501</emdnCode>
    <emdnDescription>NORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:26:25.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2-1295</udiDi>
    <basicUdiDi>B-2-1295</basicUdiDi>
    <tradeName>HQ-5DIFF HEMATOLOGY CONTROLS</tradeName>
    <deviceName>HQ-5DIFF HEMATOLOGY CONTROLS</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>W0103010501</emdnCode>
    <emdnDescription>NORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:26:24.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2-1193</udiDi>
    <basicUdiDi>B-2-1193</basicUdiDi>
    <tradeName>HQ-3DIFF HEMATOLOGY CONTROLS</tradeName>
    <deviceName>HQ-3DIFF HEMATOLOGY CONTROLS</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>W0103010501</emdnCode>
    <emdnDescription>NORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:26:22.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-179310Q2</udiDi>
    <basicUdiDi>B-179310Q2</basicUdiDi>
    <tradeName>COULTER S-CAL Calibrator Kit</tradeName>
    <deviceName>COULTER S-CAL 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>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>179310</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:17:56.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065026245233</udiDi>
    <basicUdiDi>B-15065026245233</basicUdiDi>
    <tradeName>TruCell</tradeName>
    <deviceName>CBC Kit</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC60002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:34.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-147.003.002CD</udiDi>
    <basicUdiDi>B-147.003.002CD</basicUdiDi>
    <tradeName>Hb 301 Control High</tradeName>
    <deviceName>Hb 301 Control High</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>147.003.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:18:11.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-147.002.002C2</udiDi>
    <basicUdiDi>B-147.002.002C2</basicUdiDi>
    <tradeName>Hb 301 Control Normal</tradeName>
    <deviceName>Hb 301 Control Normal</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>147.002.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:18:10.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-147.001.002BP</udiDi>
    <basicUdiDi>B-147.001.002BP</basicUdiDi>
    <tradeName>Hb 301 Control Low</tradeName>
    <deviceName>Hb 301 Control Low</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>147.001.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:18:09.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-140300LX</udiDi>
    <basicUdiDi>B-140300LX</basicUdiDi>
    <tradeName>spinit®</tradeName>
    <deviceName>spinit® BC</deviceName>
    <manufacturerName>biosurfit SA</manufacturerName>
    <manufacturerSrn>PT-MF-000033920</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010604</emdnCode>
    <emdnDescription>WHITE BLOOD CELLS (WBC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>140300</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-11T03:28:15.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>10815762020343</udiDi>
    <basicUdiDi>B-10815762020343</basicUdiDi>
    <tradeName>CBC-7 Hematology Control</tradeName>
    <deviceName>CBC-7B</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011963</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>72001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:26:40.934Z</lastUpdated>
  </row>
</eudamedExport>