<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-A025CX</udiDi>
    <basicUdiDi>B-A025CX</basicUdiDi>
    <tradeName>INDICAID™ Cervical Cancer Mutation Gene Test (Urine, Gene sequencing technology)</tradeName>
    <deviceName>INDICAID™ Cervical Cancer Mutation Gene Test (Urine, Gene sequencing technology)</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Cervical Cancer Mutation Gene Test (Urine, Gene sequencing technology)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:14:36.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A024CV</udiDi>
    <basicUdiDi>B-A024CV</basicUdiDi>
    <tradeName>NDICAID™ Cervical Cancer Methylation Test (Urine, PCR-fluorescence probe method)</tradeName>
    <deviceName>NDICAID™ Cervical Cancer Methylation Test (Urine, PCR-fluorescence probe method)</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDICAID™ Cervical Cancer Methylation Test (Urine, PCR-fluorescence probe method)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:14:35.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A023CT</udiDi>
    <basicUdiDi>B-A023CT</basicUdiDi>
    <tradeName>INDICAID™ Cervical Cancer Methylation Test (vaginal or cervical swab, gene sequencing technology)</tradeName>
    <deviceName>INDICAID™ Cervical Cancer Methylation Test (vaginal or cervical swab, gene sequencing technology)</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Cervical Cancer Methylation Test (vaginal or cervical swab, gene sequencing technology)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:14:35.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A022CR</udiDi>
    <basicUdiDi>B-A022CR</basicUdiDi>
    <tradeName>INDICAID™ Cervical Cancer Methylation Test (vaginal or cervical swab, PCR-fluorescent probe method)</tradeName>
    <deviceName>INDICAID™ Cervical Cancer Methylation Test (vaginal or cervical swab, PCR-fluorescent probe method)</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Cervical Cancer Methylation Test (vaginal or cervical swab, PCR-fluorescent probe method)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:14:31.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-9022B8</udiDi>
    <basicUdiDi>B-9022B8</basicUdiDi>
    <tradeName>D-9022B8</tradeName>
    <deviceName>Unique Dual Index Plate for Illumina®</deviceName>
    <manufacturerName>NimaGen BV</manufacturerName>
    <manufacturerSrn>NL-MF-000022926</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>IDX096-U0X(X)-I</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:55:06.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-9021B6</udiDi>
    <basicUdiDi>B-9021B6</basicUdiDi>
    <tradeName>D-9021B6</tradeName>
    <deviceName>Partner and Localiser of BRCA2 (PALB2) Library Prep Kit for Illumina®</deviceName>
    <manufacturerName>NimaGen BV</manufacturerName>
    <manufacturerSrn>NL-MF-000022926</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RC-PALB096-I</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:55:05.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-9020B4</udiDi>
    <basicUdiDi>B-9020B4</basicUdiDi>
    <tradeName>D-9020B4</tradeName>
    <deviceName>Tumour Protein p53 gene (TP53) Library Prep Kit for Illumina®</deviceName>
    <manufacturerName>NimaGen BV</manufacturerName>
    <manufacturerSrn>NL-MF-000022926</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060201</emdnCode>
    <emdnDescription>P53</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RC-TP53096-I</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:55:02.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-9018BH</udiDi>
    <basicUdiDi>B-9018BH</basicUdiDi>
    <tradeName>D-9018BH</tradeName>
    <deviceName>Cystic Fibrosis Transmembrane Conductance Regulator Gene (CFTR) Library Prep Kit for Illumina®</deviceName>
    <manufacturerName>NimaGen BV</manufacturerName>
    <manufacturerSrn>NL-MF-000022926</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RC-CFTR096-I</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:55:00.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-9019BK</udiDi>
    <basicUdiDi>B-9019BK</basicUdiDi>
    <tradeName>D-9019BK</tradeName>
    <deviceName>Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2) Library Prep Kit for Illumina®</deviceName>
    <manufacturerName>NimaGen BV</manufacturerName>
    <manufacturerSrn>NL-MF-000022926</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RC-BRCA096-I</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:54:59.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-9017BF</udiDi>
    <basicUdiDi>B-9017BF</basicUdiDi>
    <tradeName>D-9017BF</tradeName>
    <deviceName>Cystic Fibrosis Transmembrane Conductance Regulator Gene (CFTR) Mutation Hotspots Library Prep Kit for Illumina®</deviceName>
    <manufacturerName>NimaGen BV</manufacturerName>
    <manufacturerSrn>NL-MF-000022926</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RC-CFHS096-I</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:54:55.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-90085-RTFE</udiDi>
    <basicUdiDi>B-90085-RTFE</basicUdiDi>
    <tradeName>D-90085-RTFE</tradeName>
    <deviceName>EliGene® CELIAC DQ PLUS RT</deviceName>
    <manufacturerName>ELISABETH PHARMACON, spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000025244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90085-RT</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:54:36.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-90071-RTE7</udiDi>
    <basicUdiDi>B-90071-RTE7</basicUdiDi>
    <tradeName>D-90071-RTE7</tradeName>
    <deviceName>EliGene® Coeliac 3.0 RT</deviceName>
    <manufacturerName>ELISABETH PHARMACON, spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000025244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90071-RT</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:54:35.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-57BL</udiDi>
    <basicUdiDi>B-8844342-57BL</basicUdiDi>
    <tradeName>KMRtrack® KMR057</tradeName>
    <deviceName>KMRtrack® KMR057</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8844342-57</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:20.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-56BJ</udiDi>
    <basicUdiDi>B-8844342-56BJ</basicUdiDi>
    <tradeName>KMRtrack® KMR056</tradeName>
    <deviceName>KMRtrack® KMR056</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8844342-56</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:19.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-55BG</udiDi>
    <basicUdiDi>B-8844342-55BG</basicUdiDi>
    <tradeName>KMRtrack® KMR055</tradeName>
    <deviceName>KMRtrack® KMR055</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8844342-55</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:19.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-54BE</udiDi>
    <basicUdiDi>B-8844342-54BE</basicUdiDi>
    <tradeName>KMRtrack® KMR054</tradeName>
    <deviceName>KMRtrack® KMR054</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8844342-54</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:15.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-53BC</udiDi>
    <basicUdiDi>B-8844342-53BC</basicUdiDi>
    <tradeName>KMRtrack® KMR053</tradeName>
    <deviceName>KMRtrack® KMR053</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>844342-53</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:14.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-52BA</udiDi>
    <basicUdiDi>B-8844342-52BA</basicUdiDi>
    <tradeName>KMRtrack® KMR052</tradeName>
    <deviceName>KMRtrack® KMR052</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>844342-52</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:13.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-51B8</udiDi>
    <basicUdiDi>B-8844342-51B8</basicUdiDi>
    <tradeName>KMRtrack® KMR051</tradeName>
    <deviceName>KMRtrack® KMR051</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8844342-51</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:12.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8844342-50B6</udiDi>
    <basicUdiDi>B-8844342-50B6</basicUdiDi>
    <tradeName>KMRtrack® KMR050</tradeName>
    <deviceName>KMRtrack® KMR050</deviceName>
    <manufacturerName>Genome Diagnostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000453</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8844342-50</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:08.689Z</lastUpdated>
  </row>
</eudamedExport>