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<eudamedExport entity="devices">
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    <udiDi>15420045509160</udiDi>
    <basicUdiDi>54200455DIAGAPTMGENY9</basicUdiDi>
    <tradeName>Aptima Mycoplasma genitalium Assay Calibrators Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-03393</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T15:39:57.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045509566</udiDi>
    <basicUdiDi>54200455DIAGAPTHPVBR</basicUdiDi>
    <tradeName>Aptima HPV Assay Calibrators Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>302554</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T15:39:57.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045512085</udiDi>
    <basicUdiDi>54200455DIAGAPTCVTV2E</basicUdiDi>
    <tradeName>Aptima CV/TV Assay Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070501</emdnCode>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-05191</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T15:39:57.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504875</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>ATEC MRI Breast Biopsy and Excision System Handpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045852</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATEC 0914-12MR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T14:54:40.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504899</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>ATEC MRI Breast Biopsy and Excision System Handpiece</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045852</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A018003</emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATEC 0914-20MR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T14:54:40.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045514836</udiDi>
    <basicUdiDi>54200455FAXITRONCABXRAYBU</basicUdiDi>
    <tradeName>Faxitron Path Specimen Radiography System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003332</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069005</emdnCode>
    <emdnDescription>DIAGNOSTIC IMAGING WORKSTATIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PATHVISION23X29</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:06:22.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045514928</udiDi>
    <basicUdiDi>54200455FAXITRONCABXRAYBU</basicUdiDi>
    <tradeName>Faxitron Path+ Specimen Radiography System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003332</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069005</emdnCode>
    <emdnDescription>DIAGNOSTIC IMAGING WORKSTATIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PATHVISIONXL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:06:22.639Z</lastUpdated>
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