<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04987562489602</udiDi>
    <basicUdiDi>4987562ConnectionUnitVK</basicUdiDi>
    <tradeName>CF-70</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02029080</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH699752</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:23.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562497614</udiDi>
    <basicUdiDi>4987562XNsamplerunitND</basicUdiDi>
    <tradeName>SA-90</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02029080</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX718746</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:23.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562509508</udiDi>
    <basicUdiDi>4987562XNseriesUnitsHT</basicUdiDi>
    <tradeName>BT-50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02029080</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AN735871</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:22.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562510764</udiDi>
    <basicUdiDi>4987562XNsamplerunitND</basicUdiDi>
    <tradeName>SA-01</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02029080</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AZ182223</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:22.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562510771</udiDi>
    <basicUdiDi>4987562XNsamplerunitND</basicUdiDi>
    <tradeName>SA-10</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02029080</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH494484</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:22.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562510788</udiDi>
    <basicUdiDi>4987562XNsamplerunitND</basicUdiDi>
    <tradeName>SA-20</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02029080</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM076584</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:22.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562510795</udiDi>
    <basicUdiDi>4987562XNsamplerunitND</basicUdiDi>
    <tradeName>SA-21</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02029080</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AE317998</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:22.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562510801</udiDi>
    <basicUdiDi>4987562XNseriesUnitsHT</basicUdiDi>
    <tradeName>SA-31</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02029080</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG475597</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:22.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562518692</udiDi>
    <basicUdiDi>4987562XNsamplerunitND</basicUdiDi>
    <tradeName>SA-90</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02029080</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX718746</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:22.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260277174835</udiDi>
    <basicUdiDi>426027717MM.017WQ</basicUdiDi>
    <tradeName>Docon Seal</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Möller Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005100</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02029008</emdnCode>
    <emdnDescription>TUBING WELDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00003900</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T14:24:50.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262370480035</udiDi>
    <basicUdiDi>B-04262370480035</basicUdiDi>
    <tradeName>HER2 Quantifier clinical</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VMscope GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023540</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02029092</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HER2 Quantifier clinical</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:58:34.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262370480028</udiDi>
    <basicUdiDi>B-04262370480028</basicUdiDi>
    <tradeName>ER-PR Quantifier clinical</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VMscope GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023540</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02029092</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ER-PR Quantifier clinical</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:58:33.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262370480011</udiDi>
    <basicUdiDi>B-04262370480011</basicUdiDi>
    <tradeName>Ki-67 Quantifier clinical</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VMscope GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000023540</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02029092</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ki-67 Quantifier clinical</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:58:31.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>18429889002209</udiDi>
    <basicUdiDi>8429889-TF-2000-M2</basicUdiDi>
    <tradeName>Erythrocyte Sedimentation Rate Devices (ESR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AQUISEL S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000020750</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1780010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:03:30.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>18429889001226</udiDi>
    <basicUdiDi>8429889-TF-2000-M2</basicUdiDi>
    <tradeName>Erythrocyte Sedimentation Rate Devices (ESR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AQUISEL S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000020750</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1780225</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:03:30.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>18429889001233</udiDi>
    <basicUdiDi>8429889-TF-2000-M2</basicUdiDi>
    <tradeName>Erythrocyte Sedimentation Rate Devices (ESR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AQUISEL S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000020750</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1780226</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:03:29.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>18429889002247</udiDi>
    <basicUdiDi>8429889-TF-2000-M2</basicUdiDi>
    <tradeName>Erythrocyte Sedimentation Rate Devices (ESR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AQUISEL S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000020750</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1780250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:03:25.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>18429889001844</udiDi>
    <basicUdiDi>8429889-TF-2000-M2</basicUdiDi>
    <tradeName>Erythrocyte Sedimentation Rate Devices (ESR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AQUISEL S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000020750</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1740100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:03:06.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>18429889001141</udiDi>
    <basicUdiDi>8429889-TF-2000-M2</basicUdiDi>
    <tradeName>Erythrocyte Sedimentation Rate Devices (ESR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AQUISEL S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000020750</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1760200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:03:05.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972129852034</udiDi>
    <basicUdiDi>697212985BL100094</basicUdiDi>
    <tradeName>Digital Slide Scanning &amp; Imaging System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hunan Lituo Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029972</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LTS-BL400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:37:40.121Z</lastUpdated>
  </row>
</eudamedExport>