<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-CW6792878P</udiDi>
    <basicUdiDi>B-CW6792878P</basicUdiDi>
    <tradeName>D-CW6792878P</tradeName>
    <deviceName>XN CHECK</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CW679287</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T10:39:22.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CU2486464X</udiDi>
    <basicUdiDi>B-CU2486464X</basicUdiDi>
    <tradeName>D-CU2486464X</tradeName>
    <deviceName>XN CHECK</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CU248646</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T10:38:50.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CT7029734B</udiDi>
    <basicUdiDi>B-CT7029734B</basicUdiDi>
    <tradeName>D-CT7029734B</tradeName>
    <deviceName>XN CHECK</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT702973</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T10:34:16.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CL552365XY</udiDi>
    <basicUdiDi>B-CL552365XY</basicUdiDi>
    <tradeName>D-CL552365XY</tradeName>
    <deviceName>e-CHECK(XS)</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL552365</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:07:03.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CC211992RE</udiDi>
    <basicUdiDi>B-CC211992RE</basicUdiDi>
    <tradeName>D-CC211992RE</tradeName>
    <deviceName>XN-L CHECK</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC211992</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:56:08.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C07297V5</udiDi>
    <basicUdiDi>B-C07297V5</basicUdiDi>
    <tradeName>COULTER 6C Plus Cell Control</tradeName>
    <deviceName>COULTER 6C Plus Cell Control</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>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07297</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:50:28.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BS6605463P</udiDi>
    <basicUdiDi>B-BS6605463P</basicUdiDi>
    <tradeName>D-BS6605463P</tradeName>
    <deviceName>XN-L CHECK</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS660546</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:29:20.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BS4858985Q</udiDi>
    <basicUdiDi>B-BS4858985Q</basicUdiDi>
    <tradeName>D-BS4858985Q</tradeName>
    <deviceName>EIGHTCHECK-3WP</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS485898</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:29:19.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BP122483X3</udiDi>
    <basicUdiDi>B-BP122483X3</basicUdiDi>
    <tradeName>D-BP122483X3</tradeName>
    <deviceName>e-CHECK(XS)</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP122483</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:28:26.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BI00004236B</udiDi>
    <basicUdiDi>B-BI00004236B</basicUdiDi>
    <tradeName>B-Trol ESR Control L2</tradeName>
    <deviceName>B-Trol ESR Control L2</deviceName>
    <manufacturerName>Labquality Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000019825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BI0000423</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:34.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BI000042269</udiDi>
    <basicUdiDi>B-BI000042269</basicUdiDi>
    <tradeName>B-Trol ESR Control L2</tradeName>
    <deviceName>B-Trol ESR Control L2</deviceName>
    <manufacturerName>Labquality Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000019825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BI0000422</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:33.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BI000042167</udiDi>
    <basicUdiDi>B-BI000042167</basicUdiDi>
    <tradeName>B-Trol ESR Control L1</tradeName>
    <deviceName>B-Trol ESR Control L1</deviceName>
    <manufacturerName>Labquality Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000019825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010501</emdnCode>
    <emdnDescription>NORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BI0000421</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:32.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BI000042065</udiDi>
    <basicUdiDi>B-BI000042065</basicUdiDi>
    <tradeName>B-Trol ESR Control L1</tradeName>
    <deviceName>B-Trol ESR Control L1</deviceName>
    <manufacturerName>Labquality Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000019825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010501</emdnCode>
    <emdnDescription>NORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BI0000420</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:32.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BI000017269</udiDi>
    <basicUdiDi>B-BI000017269</basicUdiDi>
    <tradeName>B-Trol Plus Control Abnormal Level</tradeName>
    <deviceName>B-Trol Plus Control Abnormal Level</deviceName>
    <manufacturerName>Labquality Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000019825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BI0000172</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:28.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BI000017065</udiDi>
    <basicUdiDi>B-BI000017065</basicUdiDi>
    <tradeName>B-Trol Plus Control Normal Level</tradeName>
    <deviceName>B-Trol Plus Control Normal Level</deviceName>
    <manufacturerName>Labquality Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000019825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010501</emdnCode>
    <emdnDescription>NORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BI0000170</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:27.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BD007680QT</udiDi>
    <basicUdiDi>B-BD007680QT</basicUdiDi>
    <tradeName>D-BD007680QT</tradeName>
    <deviceName>XN CHECK BF</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BD007680</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:23:28.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BC553492T3</udiDi>
    <basicUdiDi>B-BC553492T3</basicUdiDi>
    <tradeName>D-BC553492T3</tradeName>
    <deviceName>XN CAL</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC553492</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:23:23.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BA448553S7</udiDi>
    <basicUdiDi>B-BA448553S7</basicUdiDi>
    <tradeName>D-BA448553S7</tradeName>
    <deviceName>XN CHECK BF</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA448553</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:23:10.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AW7985698S</udiDi>
    <basicUdiDi>B-AW7985698S</basicUdiDi>
    <tradeName>D-AW7985698S</tradeName>
    <deviceName>e-CHECK(XS)</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW798569</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:45:44.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AT9653195J</udiDi>
    <basicUdiDi>B-AT9653195J</basicUdiDi>
    <tradeName>D-AT9653195J</tradeName>
    <deviceName>EIGHTCHECK-3WP</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT965319</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:44:59.288Z</lastUpdated>
  </row>
</eudamedExport>