<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05055844905986</udiDi>
    <basicUdiDi>50558449LPA001GG</basicUdiDi>
    <tradeName>Prenatal Enumeration Probe kit</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010301</emdnCode>
    <emdnDescription>DOWN'S SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPA 001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:08:37.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844905993</udiDi>
    <basicUdiDi>50558449LPA001GG</basicUdiDi>
    <tradeName>Prenatal Enumeration Probe kit</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010301</emdnCode>
    <emdnDescription>DOWN'S SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPA 001-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:08:33.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906013</udiDi>
    <basicUdiDi>50558449LPA001GG</basicUdiDi>
    <tradeName>Prenatal Enumeration Probe kit</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010301</emdnCode>
    <emdnDescription>DOWN'S SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPA 001-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:07:23.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906075</udiDi>
    <basicUdiDi>50558449LPF001HK</basicUdiDi>
    <tradeName>FAST FISH Prenatal Enumeration Probe kit</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010305</emdnCode>
    <emdnDescription>TURNER SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPF 001-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:07:02.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906082</udiDi>
    <basicUdiDi>50558449LPF001HK</basicUdiDi>
    <tradeName>FAST FISH Prenatal Enumeration Probe kit</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010305</emdnCode>
    <emdnDescription>TURNER SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPF 001-30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:06:59.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906099</udiDi>
    <basicUdiDi>50558449LPF001HK</basicUdiDi>
    <tradeName>FAST FISH Prenatal Enumeration Probe kit</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010305</emdnCode>
    <emdnDescription>TURNER SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPF 001-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:06:33.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810022732595</udiDi>
    <basicUdiDi>081002273K41204314J</basicUdiDi>
    <tradeName>LeukoStrat CDx FLT3 Mutation Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Invivoscribe, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011736</manufacturerSrn>
    <authorisedRepresentativeName>IN VIVOSCRIBE TECHNOLOGIES</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000003774</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K4120431</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:00:43.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979469761774</udiDi>
    <basicUdiDi>6973315738996CC</basicUdiDi>
    <tradeName>VAHTS DNA Library Prep Kit for MGI</tradeName>
    <deviceName>VAHTS DNA Library Prep Kit for MGI</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDMB609ME-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:40:13.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979469761750</udiDi>
    <basicUdiDi>6973315736343AB</basicUdiDi>
    <tradeName>VAHTS DNA Library Prep Kit for Illumina</tradeName>
    <deviceName>VAHTS DNA Library Prep Kit for Illumina</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDB609ME-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:40:09.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979469761767</udiDi>
    <basicUdiDi>6973315736343AB</basicUdiDi>
    <tradeName>VAHTS DNA Library Prep Kit for Illumina</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDB609ME-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T04:38:42.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720211481376</udiDi>
    <basicUdiDi>872021148P1025D</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P102 HBB</tradeName>
    <deviceName>SALSA MLPA Probemix P102 HBB</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P102-025R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:23:40.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979469761781</udiDi>
    <basicUdiDi>6973315738996CC</basicUdiDi>
    <tradeName>VAHTS DNA Library Prep Kit for MGI</tradeName>
    <deviceName>VAHTS DNA Library Prep Kit for MGI</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDMB609ME-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:14:28.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720211481383</udiDi>
    <basicUdiDi>872021148P1025D</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P102 HBB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P102-050R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:57:51.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720211481390</udiDi>
    <basicUdiDi>872021148P1025D</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P102 HBB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P102-100R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:57:49.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033629921106</udiDi>
    <basicUdiDi>B-08033629921106</basicUdiDi>
    <tradeName>08033629921106</tradeName>
    <deviceName>Beta Globin PlusTest</deviceName>
    <manufacturerName>Nuclear Laser Medicine srl</manufacturerName>
    <manufacturerSrn>IT-MF-000025709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC104</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:52:10.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033629920994</udiDi>
    <basicUdiDi>B-08033629920994</basicUdiDi>
    <tradeName>08033629920994</tradeName>
    <deviceName>Alfa Globin Test</deviceName>
    <manufacturerName>Nuclear Laser Medicine srl</manufacturerName>
    <manufacturerSrn>IT-MF-000025709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC099</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:52:09.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033629920871</udiDi>
    <basicUdiDi>B-08033629920871</basicUdiDi>
    <tradeName>08033629920871</tradeName>
    <deviceName>CF PLUS</deviceName>
    <manufacturerName>Nuclear Laser Medicine srl</manufacturerName>
    <manufacturerSrn>IT-MF-000025709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC089</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:52:08.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033629920741</udiDi>
    <basicUdiDi>B-08033629920741</basicUdiDi>
    <tradeName>08033629920741</tradeName>
    <deviceName>Beta Globin Test</deviceName>
    <manufacturerName>Nuclear Laser Medicine srl</manufacturerName>
    <manufacturerSrn>IT-MF-000025709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC091</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:52:04.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033629920345</udiDi>
    <basicUdiDi>B-08033629920345</basicUdiDi>
    <tradeName>08033629920345</tradeName>
    <deviceName>CF DEL</deviceName>
    <manufacturerName>Nuclear Laser Medicine srl</manufacturerName>
    <manufacturerSrn>IT-MF-000025709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC033</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:52:03.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974783042912</udiDi>
    <basicUdiDi>697478304MFG0101063W</basicUdiDi>
    <tradeName>06974783042912</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>BGl Biotechnology (Wuhan) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050469</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010106</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:07:06.837Z</lastUpdated>
  </row>
</eudamedExport>