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<eudamedExport entity="devices">
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    <udiDi>D-81649002AEGFR01D6SQ</udiDi>
    <basicUdiDi>B-81649002AEGFR01D6SQ</basicUdiDi>
    <tradeName>D-81649002AEGFR01D6SQ</tradeName>
    <deviceName>EGFR Gene Mutation Detection Kit（Fluorescence PCR）</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</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>AEGFR01-AHG24E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:59:37.478Z</lastUpdated>
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  <row>
    <udiDi>10190302017305</udiDi>
    <basicUdiDi>B-10190302017305</basicUdiDi>
    <tradeName>Ion Torrent™ Oncomine™ Dx Express Test Panel</tradeName>
    <deviceName>Ion Torrent™ Oncomine™ Dx Express Test Panel, a part of Ion Torrent™ Oncomine™ Dx Express Test</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</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>A50871 (A54103, A54103RR)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:40:19.485Z</lastUpdated>
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    <udiDi>10190302015134</udiDi>
    <basicUdiDi>B-10190302015134</basicUdiDi>
    <tradeName>Oncomine™ Dx Target DNA Control v2.0 Kit</tradeName>
    <deviceName>Oncomine™ Dx Target DNA Control v2.0 Kit, a part of Oncomine™ Dx Target Test</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</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>A44913 (A49756)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:40:00.287Z</lastUpdated>
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  <row>
    <udiDi>10190302015103</udiDi>
    <basicUdiDi>B-10190302015103</basicUdiDi>
    <tradeName>Oncomine™ Dx Target Test (DNA and RNA Panel)</tradeName>
    <deviceName>Oncomine™ Dx Target Test (DNA and RNA Panel), a part of Oncomine™ Dx Target Test</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</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>A32441 (A49756)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:39:56.289Z</lastUpdated>
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  <row>
    <udiDi>10190302014335</udiDi>
    <basicUdiDi>B-10190302014335</basicUdiDi>
    <tradeName>Oncomine™ Dx Target RNA Control Diluent</tradeName>
    <deviceName>Oncomine™ Dx Target RNA Control Diluent, a part of Oncomine™ Dx Target Test</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</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>A38872 (A49756)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:39:55.492Z</lastUpdated>
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  <row>
    <udiDi>10190302006880</udiDi>
    <basicUdiDi>B-10190302006880</basicUdiDi>
    <tradeName>Oncomine™ Solid Tumour Fusion Transcript Kit (Part 2 of 2)</tradeName>
    <deviceName>Oncomine™ Solid Tumour Fusion Transcript Kit (Part 2 of 2), a part of Oncomine™ Solid Tumour Kits</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</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>A2676202 (A26762)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:39:54.673Z</lastUpdated>
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  <row>
    <udiDi>10190302006873</udiDi>
    <basicUdiDi>B-10190302006873</basicUdiDi>
    <tradeName>Oncomine™ Solid Tumour Fusion Transcript Kit (Part 1 of 2)</tradeName>
    <deviceName>Oncomine™ Solid Tumour Fusion Transcript Kit (Part 1 of 2), a part of Oncomine™ Solid Tumour Kits</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</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>A2676201 (A26762)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:39:53.882Z</lastUpdated>
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  <row>
    <udiDi>10190302006866</udiDi>
    <basicUdiDi>B-10190302006866</basicUdiDi>
    <tradeName>Oncomine™ Solid Tumour DNA Kit (Part 2 of 2)</tradeName>
    <deviceName>Oncomine™ Solid Tumour DNA Kit (Part 2 of 2), a part of Oncomine™ Solid Tumour Kits</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</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>A2676102 (A26761)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:39:49.886Z</lastUpdated>
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  <row>
    <udiDi>10190302006859</udiDi>
    <basicUdiDi>B-10190302006859</basicUdiDi>
    <tradeName>Oncomine™ Solid Tumour DNA Kit (Part 1 of 2)</tradeName>
    <deviceName>Oncomine™ Solid Tumour DNA Kit (Part 1 of 2), a part of Oncomine™ Solid Tumour Kits</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</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>A2676101 (A26761)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:39:49.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302006156</udiDi>
    <basicUdiDi>B-10190302006156</basicUdiDi>
    <tradeName>Ion Torrent™ Dx No Template Control Kit</tradeName>
    <deviceName>Ion Torrent™ Dx No Template Control Kit, a part of Oncomine™ Dx Target Test</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</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>A32444 (A49756)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:39:42.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302006064</udiDi>
    <basicUdiDi>B-10190302006064</basicUdiDi>
    <tradeName>Oncomine™ Dx Target RNA Control Kit</tradeName>
    <deviceName>Oncomine™ Dx Target RNA Control Kit, a part of Oncomine™ Dx Target Test</deviceName>
    <manufacturerName>Life Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000023929</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</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>A32443 (A49756)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:39:41.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013956108</udiDi>
    <basicUdiDi>B-08885013956108</basicUdiDi>
    <tradeName>Sentosa SQ Thyroid Cancer Panel (4x8)</tradeName>
    <deviceName>Sentosa SQ Thyroid Cancer Panel (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>690034</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:19:46.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013956085</udiDi>
    <basicUdiDi>B-08885013956085</basicUdiDi>
    <tradeName>Sentosa SQ CRC Panel (4x8)</tradeName>
    <deviceName>Sentosa SQ CRC Panel (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>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>690012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:19:45.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013956061</udiDi>
    <basicUdiDi>B-08885013956061</basicUdiDi>
    <tradeName>Sentosa SQ NSCLC Panel (4x8)</tradeName>
    <deviceName>Sentosa SQ NSCLC Panel (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>690010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:19:40.372Z</lastUpdated>
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  <row>
    <udiDi>08885013953947</udiDi>
    <basicUdiDi>B-08885013953947</basicUdiDi>
    <tradeName>Sentosa SA BCR-ABL minor Quantitative RT-PCR Test v2.0 (4x8)</tradeName>
    <deviceName>Sentosa SA BCR-ABL minor 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>300755</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:18:06.873Z</lastUpdated>
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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>
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  <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>
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  <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>
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  <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>
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