<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06429810590077</udiDi>
    <basicUdiDi>6429810590MGU30009PB</basicUdiDi>
    <tradeName>06429810590077</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grundium Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000005144</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MGU-30009</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:40:23.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>06429810590060</udiDi>
    <basicUdiDi>6429810590MGU30008P9</basicUdiDi>
    <tradeName>06429810590060</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Grundium Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000005144</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MGU-30008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:40:23.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>06429810590046</udiDi>
    <basicUdiDi>6429810590MGU00005N2</basicUdiDi>
    <tradeName>06429810590046</tradeName>
    <deviceName>Grundium Ocus20</deviceName>
    <manufacturerName>Grundium Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000005144</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MGU-00005</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:40:23.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>06429810590022</udiDi>
    <basicUdiDi>6429810590MGU00003MW</basicUdiDi>
    <tradeName>06429810590022</tradeName>
    <deviceName>Grundium Ocus40 MGU-00003</deviceName>
    <manufacturerName>Grundium Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000005144</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MGU-00003</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:40:18.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>06429810590008</udiDi>
    <basicUdiDi>6429810590MGU00001MS</basicUdiDi>
    <tradeName>Grundium Ocus</tradeName>
    <deviceName>Grundium Ocus</deviceName>
    <manufacturerName>Grundium Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000005144</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MGU-00001</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:40:17.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999571470273</udiDi>
    <basicUdiDi>599957147MID3UX</basicUdiDi>
    <tradeName>05999571470273</tradeName>
    <deviceName>PANNORAMIC MIDI III DX Digital Scanner</deviceName>
    <manufacturerName>3DHISTECH Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000014337</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DX-MIDI3-B0500CCAA</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:39:49.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999571470259</udiDi>
    <basicUdiDi>599957147150S4</basicUdiDi>
    <tradeName>PANNORAMIC 150 DX Digital Scanner</tradeName>
    <deviceName>PANNORAMIC 150 DX Digital Scanner</deviceName>
    <manufacturerName>3DHISTECH Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000014337</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DX-01501-B0500CCAA</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:39:48.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999571470242</udiDi>
    <basicUdiDi>599957147075SF</basicUdiDi>
    <tradeName>PANNORAMIC 75 DX Digital Scanner</tradeName>
    <deviceName>PANNORAMIC 75 DX Digital Scanner</deviceName>
    <manufacturerName>3DHISTECH Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000014337</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DX-00751-B0500CCAA</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:39:47.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999571470235</udiDi>
    <basicUdiDi>599957147036S5</basicUdiDi>
    <tradeName>PANNORAMIC 480 DX Digital Scanner</tradeName>
    <deviceName>PANNORAMIC 480 DX Digital Scanner</deviceName>
    <manufacturerName>3DHISTECH Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000014337</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DX-04802-B1200ACAA</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:39:47.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999571470204</udiDi>
    <basicUdiDi>5999571470020HA</basicUdiDi>
    <tradeName>PANNORAMIC Flash DESK DX Digital Scanner</tradeName>
    <deviceName>PANNORAMIC Flash DESK DX Digital Scanner</deviceName>
    <manufacturerName>3DHISTECH Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000014337</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DX-FLDE1-B1200ABAA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:39:43.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999571470167</udiDi>
    <basicUdiDi>5999571470266JC</basicUdiDi>
    <tradeName>PANNORAMIC 250 Flash III DX Digital Scanner</tradeName>
    <deviceName>PANNORAMIC 250 Flash III DX Digital Scanner</deviceName>
    <manufacturerName>3DHISTECH Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000014337</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DX-02503-F1205ACBA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:39:42.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999571470129</udiDi>
    <basicUdiDi>599957147046S8</basicUdiDi>
    <tradeName>PANNORAMIC 1000 DX Digital Scanner</tradeName>
    <deviceName>PANNORAMIC 1000 DX Digital Scanner</deviceName>
    <manufacturerName>3DHISTECH Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000014337</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DX-10001-B1200AAAA</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:39:40.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>05992795000257</udiDi>
    <basicUdiDi>599279507WV</basicUdiDi>
    <tradeName>HemOcular Slide Reader</tradeName>
    <deviceName>HemOcular Slide Reader</deviceName>
    <manufacturerName>Diagon Diagnosztikai Korlátolt Felelősségű Társaság</manufacturerName>
    <manufacturerSrn>HU-MF-000023582</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>g-Hemocular</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:29:24.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060905850082</udiDi>
    <basicUdiDi>506090585AAA003S7</basicUdiDi>
    <tradeName>Glissando RS2</tradeName>
    <deviceName>Glissando RS2</deviceName>
    <manufacturerName>Objective Imaging Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016742</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLISS-RS2-IVD</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:56:55.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060905850068</udiDi>
    <basicUdiDi>506090585AAA002S5</basicUdiDi>
    <tradeName>Glissando RS20</tradeName>
    <deviceName>Glissando RS20</deviceName>
    <manufacturerName>Objective Imaging Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016742</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLISS-RS20-IVD</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:56:54.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060905850037</udiDi>
    <basicUdiDi>506090585AAA001S3</basicUdiDi>
    <tradeName>Glissando 20SL</tradeName>
    <deviceName>Glissando 20SL Desktop Scanner</deviceName>
    <manufacturerName>Objective Imaging Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016742</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLISS-20SL-40X-IVD</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:56:50.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060905850006</udiDi>
    <basicUdiDi>506090585AAA000RZ</basicUdiDi>
    <tradeName>Glissando Desktop Scanner</tradeName>
    <deviceName>Glissando Desktop Scanner</deviceName>
    <manufacturerName>Objective Imaging Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016742</manufacturerSrn>
    <authorisedRepresentativeName>Acorn Regulatory Consultancy Services Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000592</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLISSR2-40X-IVD</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:56:49.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051663010467</udiDi>
    <basicUdiDi>5051663SDL025KG</basicUdiDi>
    <tradeName>Epredia E1000 Dx Digital Pathology Solution</tradeName>
    <deviceName>E1000 Dx Digital Pathology Solution</deviceName>
    <manufacturerName>Shandon Diagnostics Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000008187</manufacturerSrn>
    <authorisedRepresentativeName>Epredia Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001488</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A85200002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:04:11.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562444779</udiDi>
    <basicUdiDi>4987562UD-1037</basicUdiDi>
    <tradeName>UD-10</tradeName>
    <deviceName>Fully Automated Urine Particle Digital Imaging Device</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>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CJ445012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:41:38.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562468041</udiDi>
    <basicUdiDi>4987562SP-505H</basicUdiDi>
    <tradeName>SP-50</tradeName>
    <deviceName>Automated Hematology Slide Preparation Unit</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>IVDR 2017/746</legislation>
    <emdnCode>W0202050304</emdnCode>
    <emdnDescription>DIGITAL LABORATORY MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX765805</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:35:47.758Z</lastUpdated>
  </row>
</eudamedExport>