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    <udiDi>D-G2MBR00001K8</udiDi>
    <basicUdiDi>B-G2MBR00001K8</basicUdiDi>
    <tradeName>BRCA 1/2 Panel</tradeName>
    <deviceName>BRCA 1/2 Panel</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2MBR00001-ill,G2MBR00001-MG,G2MBR00001-TF</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:45:27.865Z</lastUpdated>
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    <udiDi>D-9019BK</udiDi>
    <basicUdiDi>B-9019BK</basicUdiDi>
    <tradeName>D-9019BK</tradeName>
    <deviceName>Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2) Library Prep Kit for Illumina®</deviceName>
    <manufacturerName>NimaGen BV</manufacturerName>
    <manufacturerSrn>NL-MF-000022926</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RC-BRCA096-I</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:54:59.713Z</lastUpdated>
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  <row>
    <udiDi>8681957090034DQ</udiDi>
    <basicUdiDi>B-8681957090034DQ</basicUdiDi>
    <tradeName>MULTIGEN</tradeName>
    <deviceName>Yeni Nesil Dizi Analizi ile BRCA1 ve BRCA2 Mutasyonlarını Saptama Kiti</deviceName>
    <manufacturerName>MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000050129</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-BR-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T12:41:53.353Z</lastUpdated>
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    <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>07350040631775</udiDi>
    <basicUdiDi>B-07350040631775</basicUdiDi>
    <tradeName>Devyser BRCA</tradeName>
    <deviceName>Devyser BRCA</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A100-24</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:59.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040631270</udiDi>
    <basicUdiDi>B-07350040631270</basicUdiDi>
    <tradeName>Devyser BRCA</tradeName>
    <deviceName>Devyser BRCA</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A100-96</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:37.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350040631263</udiDi>
    <basicUdiDi>B-07350040631263</basicUdiDi>
    <tradeName>Devyser BRCA</tradeName>
    <deviceName>Devyser BRCA</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A100-8</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:37.190Z</lastUpdated>
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    <udiDi>06974968584039</udiDi>
    <basicUdiDi>B-06974968584039</basicUdiDi>
    <tradeName>GeneMind</tradeName>
    <deviceName>BRCA1 and BRCA2 Gene Mutation Detection Kit ( Reversible Terminator Sequencing)</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L000178</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:08:09.816Z</lastUpdated>
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  <row>
    <udiDi>06974968583162</udiDi>
    <basicUdiDi>B-06974968583162</basicUdiDi>
    <tradeName>BRCA1 and BRCA2 Gene Mutation Detection Kit ( Reversible Terminator Sequencing)</tradeName>
    <deviceName>BRCA1 and BRCA2 Gene Mutation Detection Kit ( Reversible Terminator Sequencing)</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L000043</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:07:30.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959094210519</udiDi>
    <basicUdiDi>B-06959094210519</basicUdiDi>
    <tradeName>06959094210519</tradeName>
    <deviceName>AmoyDx® BRCA Pro Panel</deviceName>
    <manufacturerName>Amoy Diagnostics Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000021843</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.06.0104</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:30:44.357Z</lastUpdated>
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