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<eudamedExport entity="devices">
  <row>
    <udiDi>D-TRMF000028405HERRT24KJ</udiDi>
    <basicUdiDi>B-TRMF000028405HERRT24KJ</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP HER-2 Expression Analysis Kit, 24T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HER-RT24</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:34.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000049232R3400896XR</udiDi>
    <basicUdiDi>B-CNMF000049232R3400896XR</basicUdiDi>
    <tradeName>Human HER2 Gene copy number variation Detection Kit (Digital PCR Method)</tradeName>
    <deviceName>Human HER2 Gene copy number variation Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Shenzhen Biorain biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049232</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R34008-096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:21.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000049232R3400848XE</udiDi>
    <basicUdiDi>B-CNMF000049232R3400848XE</basicUdiDi>
    <tradeName>Human HER2 Gene copy number variation Detection Kit (Digital PCR Method)</tradeName>
    <deviceName>Human HER2 Gene copy number variation Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Shenzhen Biorain biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049232</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R34008-048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:19.510Z</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>08717973342748</udiDi>
    <basicUdiDi>B-08717973342748</basicUdiDi>
    <tradeName>ERBB2 (17q12)/SE 17</tradeName>
    <deviceName>ERBB2 (17q12) / SE 17</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-10701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T15:46:53.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975977072005</udiDi>
    <basicUdiDi>B-06975977072005</basicUdiDi>
    <tradeName>06975977072005</tradeName>
    <deviceName>HER-2 DNA Probe Kit</deviceName>
    <manufacturerName>Gold Probe Diagnostic Biotechnology Inc. MF</manufacturerName>
    <manufacturerSrn>CN-MF-000031524</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>600200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:16:45.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974689627152</udiDi>
    <basicUdiDi>B-06974689627152</basicUdiDi>
    <tradeName>HER2 amplification digital PCR detection kit</tradeName>
    <deviceName>HER2 amplification digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12633-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:27:28.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974689626216</udiDi>
    <basicUdiDi>B-06974689626216</basicUdiDi>
    <tradeName>HER2 amplification digital PCR detection kit</tradeName>
    <deviceName>HER2 amplification digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12633-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:23.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-06971808256378VT</udiDi>
    <basicUdiDi>B-06971808256378VT</basicUdiDi>
    <tradeName>Fast Fluorescence In Situ Hybridization Probe Kit</tradeName>
    <deviceName>Human ALK gene fusion detection probe</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-002</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:04:29.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927210914139</udiDi>
    <basicUdiDi>B-06927210914139</basicUdiDi>
    <tradeName>HER2/CEP17 Dual Color CISH Probe</tradeName>
    <deviceName>HER2/CEP17 Dual Color CISH Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0581</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:40.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927210914122</udiDi>
    <basicUdiDi>B-06927210914122</basicUdiDi>
    <tradeName>HER2/CEP17 Dual Color CISH Probe</tradeName>
    <deviceName>HER2/CEP17 Dual Color CISH Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0581</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:39.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927210914115</udiDi>
    <basicUdiDi>B-06927210914115</basicUdiDi>
    <tradeName>HER2/CEP17 Dual Color CISH Probe</tradeName>
    <deviceName>HER2/CEP17 Dual Color CISH Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0581</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:38.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927210914108</udiDi>
    <basicUdiDi>B-06927210914108</basicUdiDi>
    <tradeName>HER2/CEP17 Dual Color CISH Probe</tradeName>
    <deviceName>HER2/CEP17 Dual Color CISH Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0581</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:34.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251315807310</udiDi>
    <basicUdiDi>B-04251315807310</basicUdiDi>
    <tradeName>XL ERBB2 (HER2/NEU) amp</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MetaSystems Probes GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006315</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-6010-100-OG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T15:20:41.929Z</lastUpdated>
  </row>
</eudamedExport>