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<eudamedExport entity="devices">
  <row>
    <udiDi>08809539870137</udiDi>
    <basicUdiDi>B-08809539870137</basicUdiDi>
    <tradeName>HEMEaccuTest DNA</tradeName>
    <deviceName>HEMEaccuTest DNA</deviceName>
    <manufacturerName>NGeneBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000042887</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>NGB121V-048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:14:10.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973349358</udiDi>
    <basicUdiDi>B-08717973349358</basicUdiDi>
    <tradeName>MAF (16q23)/D16Z3</tradeName>
    <deviceName>MAF (16q23) / D16Z3</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-00116</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:53.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973349259</udiDi>
    <basicUdiDi>B-08717973349259</basicUdiDi>
    <tradeName>ESWR1 (22q12) Proximal - XL</tradeName>
    <deviceName>EWSR1 (22q12) 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-XL019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:52.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973349242</udiDi>
    <basicUdiDi>B-08717973349242</basicUdiDi>
    <tradeName>SS18 (18q11) Distal - XL</tradeName>
    <deviceName>SS18 (18q11) 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-XL018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:49.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973349235</udiDi>
    <basicUdiDi>B-08717973349235</basicUdiDi>
    <tradeName>FUS (16p11) Proximal - XL</tradeName>
    <deviceName>FUS (16p11) 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-XL017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:47.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973349228</udiDi>
    <basicUdiDi>B-08717973349228</basicUdiDi>
    <tradeName>FOXO1 (13q14) Distal - XL</tradeName>
    <deviceName>FOXO1 (13q14) 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-XL016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:46.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973349211</udiDi>
    <basicUdiDi>B-08717973349211</basicUdiDi>
    <tradeName>DDIT3 (12q13) Proximal - XL</tradeName>
    <deviceName>DDIT3 (12q13) 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-XL015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:44.990Z</lastUpdated>
  </row>
  <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>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>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>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>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>
  <row>
    <udiDi>08717973342823</udiDi>
    <basicUdiDi>B-08717973342823</basicUdiDi>
    <tradeName>MDM2 (12q15)/SE 12</tradeName>
    <deviceName>MDM2 (12q15) / SE 12</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-10717</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:46:56.061Z</lastUpdated>
  </row>
</eudamedExport>