<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05051663009768</udiDi>
    <basicUdiDi>5051663SDL011K5</basicUdiDi>
    <tradeName>CTM6</tradeName>
    <deviceName>CTM6 Coverslipper</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>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>970010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:04:03.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051663009447</udiDi>
    <basicUdiDi>5051663SDL010K3</basicUdiDi>
    <tradeName>ClearVue</tradeName>
    <deviceName>ClearVue Coverslipper</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>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A79200001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:03:52.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946433600638</udiDi>
    <basicUdiDi>49464334742UJ</basicUdiDi>
    <tradeName>Tissue-Tek Film</tradeName>
    <deviceName>Tissue-Tek Film</deviceName>
    <manufacturerName>Sakura Seiki Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000022209</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4742</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:26:47.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946433600645</udiDi>
    <basicUdiDi>49464336502UA</basicUdiDi>
    <tradeName>Tissue-Tek</tradeName>
    <deviceName>Tissue-Tek Glas g2</deviceName>
    <manufacturerName>Sakura Seiki Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000022209</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6502</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:26:45.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260248680419</udiDi>
    <basicUdiDi>42505308MEDITECOVEREA</basicUdiDi>
    <tradeName>Covertec</tradeName>
    <deviceName>Covertec FILM COVERSLIPPER</deviceName>
    <manufacturerName>SLEE medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000041949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19000000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:43:25.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>08034120272421</udiDi>
    <basicUdiDi>080341202W0202059008MF</basicUdiDi>
    <tradeName>CVR909</tradeName>
    <deviceName>Automatic coverslipper</deviceName>
    <manufacturerName>Bio-Optica Milano S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000027525</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40-500-000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:31:32.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049188227133</udiDi>
    <basicUdiDi>01040491880485A6</basicUdiDi>
    <tradeName>HistoCore CHROMAX CV</tradeName>
    <deviceName>HistoCore CHROMAX CV</deviceName>
    <manufacturerName>Leica Biosystems Nussloch GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021943</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14048562192</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:46:51.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049188203953</udiDi>
    <basicUdiDi>010404918805149L</basicUdiDi>
    <tradeName>HistoCore SPECTRA CV</tradeName>
    <deviceName>HistoCore SPECTRA CV</deviceName>
    <manufacturerName>Leica Biosystems Nussloch GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021943</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14051454200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:46:36.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049188051035</udiDi>
    <basicUdiDi>01040491880478A9</basicUdiDi>
    <tradeName>Leica CV5030</tradeName>
    <deviceName>Leica CV5030</deviceName>
    <manufacturerName>Leica Biosystems Nussloch GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021943</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14047839700</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:46:08.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>08034003040062</udiDi>
    <basicUdiDi>8034003040062-W2059008JW</basicUdiDi>
    <tradeName>CVR</tradeName>
    <deviceName>Automatic coverslipper</deviceName>
    <manufacturerName>INTELSINT S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030618</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>https://www.intelsint.com/cvr</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:23:16.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979203760322</udiDi>
    <basicUdiDi>697920376ACS001FR</basicUdiDi>
    <tradeName>CHIWELL</tradeName>
    <deviceName>Automatic Cover-Slipper</deviceName>
    <manufacturerName>Ningbo Chiwell Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000034310</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CW-180</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:30:40.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975340354226</udiDi>
    <basicUdiDi>697534035ADSACFZ</basicUdiDi>
    <tradeName>06975340354226</tradeName>
    <deviceName>Auto Drip Stainer and Coverslipper</deviceName>
    <manufacturerName>Guangdong Jinquan Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023901</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JQ-DS50</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:43:35.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971182571357</udiDi>
    <basicUdiDi>69711825728W6</basicUdiDi>
    <tradeName>Glass Coverslipper</tradeName>
    <deviceName>Glass Coverslipper</deviceName>
    <manufacturerName>Dakewe (Shenzhen) Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009696</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130.033.001-00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:39:37.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260606592019</udiDi>
    <basicUdiDi>426060659MDPM1A85</basicUdiDi>
    <tradeName>IPI Pathomat®</tradeName>
    <deviceName>IPI Pathomat</deviceName>
    <manufacturerName>Island Polymer Industries GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:50:05.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260606591029</udiDi>
    <basicUdiDi>426060659MDPS2A96</basicUdiDi>
    <tradeName>IPI Pathoslide® 2.0</tradeName>
    <deviceName>IPI Pathoslide® 2.0</deviceName>
    <manufacturerName>Island Polymer Industries GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:50:04.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260606591012</udiDi>
    <basicUdiDi>426060659MDPS1A93</basicUdiDi>
    <tradeName>IPI Pathoslide</tradeName>
    <deviceName>IPI Pathoslide</deviceName>
    <manufacturerName>Island Polymer Industries GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000011884</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:50:04.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979203760339</udiDi>
    <basicUdiDi>697920376ACS001FR</basicUdiDi>
    <tradeName>CHIWELL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Chiwell Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000034310</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CW-360</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:02:03.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979203760346</udiDi>
    <basicUdiDi>697920376ACS001FR</basicUdiDi>
    <tradeName>CHIWELL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Chiwell Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000034310</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CW-400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:02:03.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979203760353</udiDi>
    <basicUdiDi>697920376ACS001FR</basicUdiDi>
    <tradeName>CHIWELL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Chiwell Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000034310</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CW-400A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:02:03.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979203760360</udiDi>
    <basicUdiDi>697920376ACS001FR</basicUdiDi>
    <tradeName>CHIWELL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Chiwell Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000034310</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059008</emdnCode>
    <emdnDescription>AUTOMATED COVERSLIPPERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CW-400B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:02:03.053Z</lastUpdated>
  </row>
</eudamedExport>