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<eudamedExport entity="devices">
  <row>
    <udiDi>08717973349204</udiDi>
    <basicUdiDi>B-08717973349204</basicUdiDi>
    <tradeName>MDM2 (12q15) - XL</tradeName>
    <deviceName>MDM2 (12q15) / SE12 (D12Z3)- XL for BOND</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</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>KBI-XL014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:42.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973349198</udiDi>
    <basicUdiDi>B-08717973349198</basicUdiDi>
    <tradeName>CCND1 (11q13) Proximal - XL</tradeName>
    <deviceName>CCND1 (11q13) Break - XL for BOND</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</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>KBI-XL013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:40.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973349082</udiDi>
    <basicUdiDi>B-08717973349082</basicUdiDi>
    <tradeName>BCL2 (18q21) Distal - XL</tradeName>
    <deviceName>BCL2 (18q21) Break - XL for BOND</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</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>KBI-XL008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:40.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973349099</udiDi>
    <basicUdiDi>B-08717973349099</basicUdiDi>
    <tradeName>BCL6 (3q27) Proximal - XL</tradeName>
    <deviceName>BCL6 (3q27) Break - XL for BOND</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</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>KBI-XL009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:38.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973349068</udiDi>
    <basicUdiDi>B-08717973349068</basicUdiDi>
    <tradeName>MYC (8q24) Distal - XL</tradeName>
    <deviceName>MYC (8q24) Break - XL for BOND</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060205</emdnCode>
    <emdnDescription>C-MYC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-XL006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:36.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973349075</udiDi>
    <basicUdiDi>B-08717973349075</basicUdiDi>
    <tradeName>IGH (14q32) Distal - XL</tradeName>
    <deviceName>IGH (14q32) Break - XL for BOND</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</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>KBI-XL007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:33.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973349037</udiDi>
    <basicUdiDi>B-08717973349037</basicUdiDi>
    <tradeName>MET (7q31) - XL</tradeName>
    <deviceName>MET (7q31) / SE 7 (D7Z1) - XL for BOND</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060205</emdnCode>
    <emdnDescription>C-MYC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-XL003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:20.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973349020</udiDi>
    <basicUdiDi>B-08717973349020</basicUdiDi>
    <tradeName>ROS1 (6q22) Proximal XL</tradeName>
    <deviceName>ROS1 (6q22) Break - XL for BOND</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060205</emdnCode>
    <emdnDescription>C-MYC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-XL002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:18.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973349013</udiDi>
    <basicUdiDi>B-08717973349013</basicUdiDi>
    <tradeName>ALK (2p23) Proximal - XL</tradeName>
    <deviceName>ALK (2p23) Break - XL for BOND</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060205</emdnCode>
    <emdnDescription>C-MYC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-XL001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:16.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973348948</udiDi>
    <basicUdiDi>B-08717973348948</basicUdiDi>
    <tradeName>ROS1 (6q22) Break</tradeName>
    <deviceName>ROS1 (6q22) Break</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060205</emdnCode>
    <emdnDescription>C-MYC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-10752</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:14.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973348832</udiDi>
    <basicUdiDi>B-08717973348832</basicUdiDi>
    <tradeName>EWSR1 (22q12) Break</tradeName>
    <deviceName>EWSR1 (22q12) Break</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</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>KBI-10750</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:13.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973348511</udiDi>
    <basicUdiDi>B-08717973348511</basicUdiDi>
    <tradeName>MYC (8q24) Triple-Color, Break (tissue)</tradeName>
    <deviceName>MYC (8q24) Triple-Color, Break (tissue)</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060205</emdnCode>
    <emdnDescription>C-MYC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-10749</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:12.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973348207</udiDi>
    <basicUdiDi>B-08717973348207</basicUdiDi>
    <tradeName>ALK (2p23) Break</tradeName>
    <deviceName>ALK (2p23) Break</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060205</emdnCode>
    <emdnDescription>C-MYC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-10747</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:09.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973348184</udiDi>
    <basicUdiDi>B-08717973348184</basicUdiDi>
    <tradeName>BCL2 (18q21) Break (tissue)</tradeName>
    <deviceName>BCL2 (18q21) Break (tissue)</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</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>KBI-10745</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:08.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973343981</udiDi>
    <basicUdiDi>B-08717973343981</basicUdiDi>
    <tradeName>MET (7q31)/SE 7</tradeName>
    <deviceName>MET (7q31) / SE 7</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060205</emdnCode>
    <emdnDescription>C-MYC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-10719</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:07.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973342915</udiDi>
    <basicUdiDi>B-08717973342915</basicUdiDi>
    <tradeName>FOXO1 (13q14) Break</tradeName>
    <deviceName>FOXO1 (13q14) Break</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</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>KBI-10716</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:04.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973342908</udiDi>
    <basicUdiDi>B-08717973342908</basicUdiDi>
    <tradeName>FUS (16p11) Break</tradeName>
    <deviceName>FUS (16p11) Break</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</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>KBI-10715</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:02.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973342892</udiDi>
    <basicUdiDi>B-08717973342892</basicUdiDi>
    <tradeName>DDIT3 (12q13 Break</tradeName>
    <deviceName>DDIT3 (12q13) Break</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</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>KBI-10714</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:00.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973342885</udiDi>
    <basicUdiDi>B-08717973342885</basicUdiDi>
    <tradeName>SS18 (18q11) Break</tradeName>
    <deviceName>SS18 (18q11) Break</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</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>KBI-10713</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:00.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973342854</udiDi>
    <basicUdiDi>B-08717973342854</basicUdiDi>
    <tradeName>BCL6 (3q27) Break (tissue)</tradeName>
    <deviceName>BCL6 (3q27) Break (tissue)</deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</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>KBI-10730</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:46:58.472Z</lastUpdated>
  </row>
</eudamedExport>