<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05055844907294</udiDi>
    <basicUdiDi>50558449DESWT</basicUdiDi>
    <tradeName>DAPI Antifade ES</tradeName>
    <deviceName>DAPI Antifade ES</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>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-DES 1000L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:47:06.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906822</udiDi>
    <basicUdiDi>50558449LPH108JL</basicUdiDi>
    <tradeName>IGH/MAF Plus v2 Translocation, Dual Fusion Probe</tradeName>
    <deviceName>IGH/MAF Plus v2 Translocation, Dual Fusion Probe</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></emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 108</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:47:05.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906761</udiDi>
    <basicUdiDi>50558449LPH089K9</basicUdiDi>
    <tradeName>CBFB Breakapart Probe</tradeName>
    <deviceName>CBFB Breakapart Probe</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></emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 089</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:47:04.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906501</udiDi>
    <basicUdiDi>50558449LPH038JQ</basicUdiDi>
    <tradeName>BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe</tradeName>
    <deviceName>BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe</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>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 038</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:47:03.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906600</udiDi>
    <basicUdiDi>50558449LPH064JR</basicUdiDi>
    <tradeName>FAST PML/RARα (RARA) Translocation, Dual Fusion Probe</tradeName>
    <deviceName>FAST PML/RARα (RARA) Translocation, Dual Fusion Probe</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></emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 064</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:47:02.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906587</udiDi>
    <basicUdiDi>50558449LPH052JJ</basicUdiDi>
    <tradeName>P53 (TP53)/ATM Combination Deletion Probe</tradeName>
    <deviceName>P53 (TP53)/ATM Combination Deletion Probe</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></emdnCode>
    <emdnDescription>P53</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 052</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:47:02.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906525</udiDi>
    <basicUdiDi>50558449LPH039JS</basicUdiDi>
    <tradeName>CKS1B/CDKN2C (P18) Amplification/Deletion Probe</tradeName>
    <deviceName>CKS1B/CDKN2C (P18) Amplification/Deletion Probe</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></emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 039</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:47:01.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906488</udiDi>
    <basicUdiDi>50558449LPH036JL</basicUdiDi>
    <tradeName>EVI1 (MECOM) Breakapart Probe</tradeName>
    <deviceName>EVI1 (MECOM) Breakapart Probe</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></emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 036</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:46:59.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906426</udiDi>
    <basicUdiDi>50558449LPH027JK</basicUdiDi>
    <tradeName>AML1 (RUNX1) Breakapart Probe</tradeName>
    <deviceName>AML1 (RUNX1) Breakapart Probe</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></emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 027</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:46:58.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906402</udiDi>
    <basicUdiDi>50558449LPH026JH</basicUdiDi>
    <tradeName>AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion Probe</tradeName>
    <deviceName>AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion Probe</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></emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 026</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:46:58.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906389</udiDi>
    <basicUdiDi>50558449LPH025JF</basicUdiDi>
    <tradeName>Del(7q) Deletion Probe</tradeName>
    <deviceName>Del(7q) Deletion Probe</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></emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE- LPH 025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:46:57.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906365</udiDi>
    <basicUdiDi>50558449LPH024JD</basicUdiDi>
    <tradeName>Del(5q) Deletion Probe</tradeName>
    <deviceName>Del(5q) Deletion Probe</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></emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:46:56.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906341</udiDi>
    <basicUdiDi>50558449LPH022J9</basicUdiDi>
    <tradeName>CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe</tradeName>
    <deviceName>CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe</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></emdnCode>
    <emdnDescription>INV (16)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:46:55.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906327</udiDi>
    <basicUdiDi>50558449LPH020J5</basicUdiDi>
    <tradeName>Del(20q) Deletion Probe</tradeName>
    <deviceName>Del(20q) Deletion Probe</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></emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:46:54.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906242</udiDi>
    <basicUdiDi>50558449LPH013J8</basicUdiDi>
    <tradeName>MLL (KMT2A) Breakapart Probe</tradeName>
    <deviceName>MLL (KMT2A) Breakapart Probe</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></emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:46:54.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906204</udiDi>
    <basicUdiDi>50558449LPH011J4</basicUdiDi>
    <tradeName>ATM Deletion Probe</tradeName>
    <deviceName>ATM Deletion Probe</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></emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:46:53.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906181</udiDi>
    <basicUdiDi>50558449LPH007JD</basicUdiDi>
    <tradeName>BCR/ABL (ABL1) Translocation, Dual Fusion Probe</tradeName>
    <deviceName>BCR/ABL (ABL1) Translocation, Dual Fusion Probe</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></emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:46:52.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906044</udiDi>
    <basicUdiDi>50558449LPA003GL</basicUdiDi>
    <tradeName>Prenatal 13 and 21 Enumeration Probe kit</tradeName>
    <deviceName>Prenatal 13 and 21 Enumeration Probe kit</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></emdnCode>
    <emdnDescription>PÄTAU SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPA 003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:46:51.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906051</udiDi>
    <basicUdiDi>50558449LPA003GL</basicUdiDi>
    <tradeName>Prenatal 13 and 21 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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DOWN'S SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPA 003-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:56.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055844906198</udiDi>
    <basicUdiDi>50558449LPH007JD</basicUdiDi>
    <tradeName>BCR/ABL (ABL1) Translocation, Dual Fusion Probe</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPH 007-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:56.932Z</lastUpdated>
  </row>
</eudamedExport>