<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08033891322069</udiDi>
    <basicUdiDi>803389132CUBE30T00V6</basicUdiDi>
    <tradeName>CUBE 30 TOUCH</tradeName>
    <deviceName>CUBE 30 TOUCH</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10395</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:18:54.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>07791778038748</udiDi>
    <basicUdiDi>7791778W020290019351058ZP</basicUdiDi>
    <tradeName>e32</tradeName>
    <deviceName>e32</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9351058</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:08:47.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040976623</udiDi>
    <basicUdiDi>735004097XU-10135AQ</basicUdiDi>
    <tradeName>CellaVision Oil Pack 2x150ml</tradeName>
    <deviceName>CellaVision Oil Pack 2x150ml</deviceName>
    <manufacturerName>CellaVision AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029085</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XU-10135-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:51:45.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040975091</udiDi>
    <basicUdiDi>735004097XU-10301AH</basicUdiDi>
    <tradeName>CellaVision® DC-1</tradeName>
    <deviceName>CellaVision® DC-1</deviceName>
    <manufacturerName>CellaVision AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>XU-10301</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:51:44.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040974933</udiDi>
    <basicUdiDi>735004097CABDZ</basicUdiDi>
    <tradeName>CellaVision® Adv. RBC and Body Fluid DM1200 Non-Expiring License</tradeName>
    <deviceName>CellaVision® Adv. RBC and Body Fluid</deviceName>
    <manufacturerName>CellaVision AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029092</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAB-120099</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:51:44.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040974520</udiDi>
    <basicUdiDi>735004097CRRSB5</basicUdiDi>
    <tradeName>CellaVision® Remote Review Enterprise Edition Upgrade from Citrix Ready Enterprise Edition</tradeName>
    <deviceName>CellaVision® Review Software</deviceName>
    <manufacturerName>CellaVision AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029092</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRRS-ENXXUP</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:51:43.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040973745</udiDi>
    <basicUdiDi>735004097CAREZ</basicUdiDi>
    <tradeName>CellaVision® Advanced RBC Application DM1200 Non-Expiring License</tradeName>
    <deviceName>CellaVision® Advanced RBC Application</deviceName>
    <manufacturerName>CellaVision AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029092</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-120099</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:51:39.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040972557</udiDi>
    <basicUdiDi>735004097CBFEC</basicUdiDi>
    <tradeName>CellaVision® Body Fluid Application DM1200 Non-Expiring License</tradeName>
    <deviceName>CellaVision® Body Fluid Application</deviceName>
    <manufacturerName>CellaVision AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029092</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBF-120099</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:51:38.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040974476</udiDi>
    <basicUdiDi>735004097CDMS8G</basicUdiDi>
    <tradeName>CellaVision® DM Software DM1200 Upgrade from 4.0.x to 6.0.x incl. Localization DVD</tradeName>
    <deviceName>CellaVision® DM Software</deviceName>
    <manufacturerName>CellaVision AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029092</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDMS-126040</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:51:37.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040974322</udiDi>
    <basicUdiDi>735004097XU-10288BJ</basicUdiDi>
    <tradeName>CellaVision® DM9600</tradeName>
    <deviceName>CellaVision® DM9600</deviceName>
    <manufacturerName>CellaVision AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>XU-10288-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:51:36.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040972021</udiDi>
    <basicUdiDi>735004097CC286297T7</basicUdiDi>
    <tradeName>Automated Digital Cell Morphology Analyzer DI-60</tradeName>
    <deviceName>Automated Digital Cell Morphology Analyzer DI-60</deviceName>
    <manufacturerName>CellaVision AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>CC286297</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:51:19.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040971765</udiDi>
    <basicUdiDi>735004097XU-10134AN</basicUdiDi>
    <tradeName>Magazine Pack Body Fluids,  Blue, 5 pcs</tradeName>
    <deviceName>Magazine Pack Body Fluids,  Blue, 5 pcs</deviceName>
    <manufacturerName>CellaVision AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029085</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XU-10134-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:51:19.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040971741</udiDi>
    <basicUdiDi>735004097XU-10133AL</basicUdiDi>
    <tradeName>Magazine Pack Peripheral Blood Orange 10 pcs</tradeName>
    <deviceName>Magazine Pack Peripheral Blood Orange 10 pcs</deviceName>
    <manufacturerName>CellaVision AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029085</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XU-10133-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:51:18.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040971277</udiDi>
    <basicUdiDi>735004097XU-10127AR</basicUdiDi>
    <tradeName>CellaVision® DM1200</tradeName>
    <deviceName>CellaVision® DM1200</deviceName>
    <manufacturerName>CellaVision AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002377</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>XU-10127-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:51:17.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979822870242</udiDi>
    <basicUdiDi>697982287ZRCP0001UN</basicUdiDi>
    <tradeName>06979822870242</tradeName>
    <deviceName>Integrated Film Processing and Colorization Machine</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</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>ZRCP0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:47:33.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979822870235</udiDi>
    <basicUdiDi>697982287CXCP0001J7</basicUdiDi>
    <tradeName>06979822870235</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029006</emdnCode>
    <emdnDescription>APHERESIS UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTC100 Pro</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:47:32.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979822870181</udiDi>
    <basicUdiDi>697982287JPCP0001J4</basicUdiDi>
    <tradeName>06979822870181</tradeName>
    <deviceName>Droplet Printer</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</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>JPCP0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:47:25.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979822870037</udiDi>
    <basicUdiDi>697982287CFCP00018M</basicUdiDi>
    <tradeName>06979822870037</tradeName>
    <deviceName>Disposable Cell Filter</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029006</emdnCode>
    <emdnDescription>APHERESIS UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFCP0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:46:46.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979822870006</udiDi>
    <basicUdiDi>697982287CSCP0001FJ</basicUdiDi>
    <tradeName>06979822870006</tradeName>
    <deviceName>Cell Sorter</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029006</emdnCode>
    <emdnDescription>APHERESIS UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTC100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:46:44.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979497340071</udiDi>
    <basicUdiDi>697949734FACA01RM</basicUdiDi>
    <tradeName>06979497340071</tradeName>
    <deviceName>Fully automatic coagulation analyzer</deviceName>
    <manufacturerName>Jiangsu Hongen Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051431</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>H1201</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:45:17.642Z</lastUpdated>
  </row>
</eudamedExport>