<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06927210913958</udiDi>
    <basicUdiDi>B-06927210913958</basicUdiDi>
    <tradeName>ISH EBER Probe</tradeName>
    <deviceName>ISH EBER Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0577</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:11.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927210913941</udiDi>
    <basicUdiDi>B-06927210913941</basicUdiDi>
    <tradeName>ISH EBER Probe</tradeName>
    <deviceName>ISH EBER Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0577</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:14:27.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250380308234</udiDi>
    <basicUdiDi>B-04250380308234</basicUdiDi>
    <tradeName>04250380308234</tradeName>
    <deviceName>ZytoLight Bladder Cancer Quadruple Color Probe</deviceName>
    <manufacturerName>ZytoVision GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024390</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-2305-200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:40:22.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435256763218</udiDi>
    <basicUdiDi>8435421200468YE</basicUdiDi>
    <tradeName>master diagnóstica</tradeName>
    <deviceName>Fluorescent Contrast Agent - DAPI+AntiFade</deviceName>
    <manufacturerName>VITRO, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAD-FS0106-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:01:02.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>55391540380043</udiDi>
    <basicUdiDi>5391540380CL-004Q7</basicUdiDi>
    <tradeName>55391540380043</tradeName>
    <deviceName>In Situ Hybridization Staining Solution (Antifade DAPI)</deviceName>
    <manufacturerName>OACP IE LTD</manufacturerName>
    <manufacturerSrn>IE-MF-000003506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:20:50.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>53915403800626</udiDi>
    <basicUdiDi>539154038200175G9</basicUdiDi>
    <tradeName>53915403800626</tradeName>
    <deviceName>Smart-ISH Solve</deviceName>
    <manufacturerName>OACP IE LTD</manufacturerName>
    <manufacturerSrn>IE-MF-000003506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200175</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:20:49.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>53915403800558</udiDi>
    <basicUdiDi>539154038031114-HEAM</basicUdiDi>
    <tradeName>53915403800558</tradeName>
    <deviceName>Rapid-ISH Hemato</deviceName>
    <manufacturerName>OACP IE LTD</manufacturerName>
    <manufacturerSrn>IE-MF-000003506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>031114-HE</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:20:48.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>53915403800480</udiDi>
    <basicUdiDi>539154038031114-DMAR</basicUdiDi>
    <tradeName>53915403800480</tradeName>
    <deviceName>Rapid-ISH Integra Recovery</deviceName>
    <manufacturerName>OACP IE LTD</manufacturerName>
    <manufacturerSrn>IE-MF-000003506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>031114-DM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:20:48.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>53915403800312</udiDi>
    <basicUdiDi>539154038031114-MOBQ</basicUdiDi>
    <tradeName>53915403800312</tradeName>
    <deviceName>Rapid ISH Integra Plus</deviceName>
    <manufacturerName>OACP IE LTD</manufacturerName>
    <manufacturerSrn>IE-MF-000003506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>031114-MO</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:20:44.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>53915403800244</udiDi>
    <basicUdiDi>539154038031114-DOAV</basicUdiDi>
    <tradeName>53915403800244</tradeName>
    <deviceName>Rapid-ISH Integra</deviceName>
    <manufacturerName>OACP IE LTD</manufacturerName>
    <manufacturerSrn>IE-MF-000003506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>031114-DO</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:20:43.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>53915403800015</udiDi>
    <basicUdiDi>5391540380FP-001SL</basicUdiDi>
    <tradeName>53915403800015</tradeName>
    <deviceName>Human HER-2 gene amplification detection probe</deviceName>
    <manufacturerName>OACP IE LTD</manufacturerName>
    <manufacturerSrn>IE-MF-000003506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:20:42.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250380306469</udiDi>
    <basicUdiDi>4250380P296RN</basicUdiDi>
    <tradeName>04250380306469</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZytoVision GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024390</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-2210-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T18:29:20.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250380303888</udiDi>
    <basicUdiDi>4250380P189RL</basicUdiDi>
    <tradeName>04250380303888</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZytoVision GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024390</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-2130-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T18:25:29.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250380302676</udiDi>
    <basicUdiDi>4250380P082QZ</basicUdiDi>
    <tradeName>04250380302676</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZytoVision GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024390</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-2069-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T18:25:01.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250380300405</udiDi>
    <basicUdiDi>4250380P037QU</basicUdiDi>
    <tradeName>04250380300405</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZytoVision GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024390</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-2004-200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T18:24:16.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844907300</udiDi>
    <basicUdiDi>50558449DESWT</basicUdiDi>
    <tradeName>DAPI Antifade ES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-DES 500L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:56.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844935037</udiDi>
    <basicUdiDi>50558449DESWT</basicUdiDi>
    <tradeName>DAPI Antifade ES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-DES 500L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:55.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844935044</udiDi>
    <basicUdiDi>50558449DESWT</basicUdiDi>
    <tradeName>DAPI Antifade ES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-DES 1000L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:55.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250380300238</udiDi>
    <basicUdiDi>4250380N467W</basicUdiDi>
    <tradeName>04250380300238</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZytoVision GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024390</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C-3022-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:01:49.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250380300542</udiDi>
    <basicUdiDi>4250380N447S</basicUdiDi>
    <tradeName>04250380300542</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZytoVision GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024390</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-2020-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:01:48.932Z</lastUpdated>
  </row>
</eudamedExport>