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<eudamedExport entity="devices">
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    <udiDi>08885013953930</udiDi>
    <basicUdiDi>B-08885013953930</basicUdiDi>
    <tradeName>Sentosa SA BCR-ABL Major Quantitative RT-PCR Test v2.0 (4x8)</tradeName>
    <deviceName>Sentosa SA BCR-ABL Major Quantitative RT-PCR Test v2.0 (4x8)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</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>300753</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:18:04.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013953190</udiDi>
    <basicUdiDi>B-08885013953190</basicUdiDi>
    <tradeName>Sentosa SA NRAS PCR Test (4x8)</tradeName>
    <deviceName>Sentosa SA NRAS PCR Test (4x8)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</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>300086</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:17:01.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013953183</udiDi>
    <basicUdiDi>B-08885013953183</basicUdiDi>
    <tradeName>Sentosa SA KRAS PCR Test (4x8)</tradeName>
    <deviceName>Sentosa SA KRAS PCR Test (4x8)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</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>300083</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:17:00.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013953176</udiDi>
    <basicUdiDi>B-08885013953176</basicUdiDi>
    <tradeName>Sentosa SA BRAF V600 PCR Test (4x8)</tradeName>
    <deviceName>Sentosa SA BRAF V600 PCR Test (4x8)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</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>300003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:16:59.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809740940087</udiDi>
    <basicUdiDi>B-08809740940087</basicUdiDi>
    <tradeName>Dr. PCR™ BCR-ABL1 Major IS Detection Kit</tradeName>
    <deviceName>Dr. PCR™ BCR-ABL1 Major IS Detection Kit</deviceName>
    <manufacturerName>OPTOLANE Technologies Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000026042</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DON01-X</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T13:40:50.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809539870458</udiDi>
    <basicUdiDi>B-08809539870458</basicUdiDi>
    <tradeName>ONCOaccuPanel</tradeName>
    <deviceName>ONCOaccu Panel</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>NGB162V-060</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:14:16.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809539870281</udiDi>
    <basicUdiDi>B-08809539870281</basicUdiDi>
    <tradeName>SOLIDaccuTest DNA</tradeName>
    <deviceName>SOLIDaccuTest 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>NGB131V-096</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:14:15.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809539870267</udiDi>
    <basicUdiDi>B-08809539870267</basicUdiDi>
    <tradeName>SOLIDaccuTest DNA</tradeName>
    <deviceName>SOLIDaccuTest 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>NGB131V-048</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:14:11.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809539870151</udiDi>
    <basicUdiDi>B-08809539870151</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-096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:14:10.867Z</lastUpdated>
  </row>
  <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>08809539870106</udiDi>
    <basicUdiDi>B-08809539870106</basicUdiDi>
    <tradeName>BRCAaccuTest PLUS</tradeName>
    <deviceName>BRCAaccuTest PLUS</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>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGB112V-024</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:14:09.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809539870083</udiDi>
    <basicUdiDi>B-08809539870083</basicUdiDi>
    <tradeName>BRCAaccuTest PLUS</tradeName>
    <deviceName>BRCAaccuTest PLUS</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>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGB112V-012</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:14:05.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809378688948</udiDi>
    <basicUdiDi>B-08809378688948</basicUdiDi>
    <tradeName>08809378688948</tradeName>
    <deviceName>PNAClamp™ KRAS Mutation Detection Kit (Ver.4)</deviceName>
    <manufacturerName>HLB PANAGENE</manufacturerName>
    <manufacturerSrn>KR-MF-000042004</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060202</emdnCode>
    <emdnDescription>K-RAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PNAC-1006</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:46:09.281Z</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>08717973349266</udiDi>
    <basicUdiDi>B-08717973349266</basicUdiDi>
    <tradeName>SE 17 (D17Z1) - XL</tradeName>
    <deviceName>ERBB2 (17q12) / SE 17 - 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>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-XL020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:47:53.090Z</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>
</eudamedExport>