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<eudamedExport entity="devices">
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    <udiDi>05420045503369</udiDi>
    <basicUdiDi>54200455TRIMARKBSH5X</basicUdiDi>
    <tradeName>ATEC TriMark Titanium Biopsy Site Marker</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></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRIMARKTD-2S-36-12</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:07.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420045503550</udiDi>
    <basicUdiDi>54200455TRIMARKBSH5X</basicUdiDi>
    <tradeName>TriMark for Eviva Titanium Biopsy Site Marker</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></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRIMARK-EVIVA-10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:07.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420045503567</udiDi>
    <basicUdiDi>54200455TRIMARKBSH5X</basicUdiDi>
    <tradeName>TriMark for Eviva Titanium Biopsy Site Marker</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></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRIMARK-EVIVA-2S-10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:07.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420045503574</udiDi>
    <basicUdiDi>54200455TRIMARKBSH5X</basicUdiDi>
    <tradeName>TriMark for Eviva Titanium Biopsy Site Marker</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></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRIMARK-EVIVA-13</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:07.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420045503581</udiDi>
    <basicUdiDi>54200455TRIMARKBSH5X</basicUdiDi>
    <tradeName>TriMark for Eviva Titanium Biopsy Site Marker</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></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRIMARK-EVIVA-2S-13</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:07.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420045503710</udiDi>
    <basicUdiDi>54200455BRSTSNGTFGK</basicUdiDi>
    <tradeName>Eviva Needle Guide</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045852</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEEDLE GUIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVIVA_NG09L</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:07.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420045503734</udiDi>
    <basicUdiDi>54200455BRSTSNGTFGK</basicUdiDi>
    <tradeName>Eviva Needle Guide</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045852</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEEDLE GUIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVIVA_NG12L</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:07.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504561</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>ATEC Breast Biopsy and Excision System Ultrasound Introducer</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AI090920</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:23:58.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504578</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>ATEC Breast Biopsy and Excision System Ultrasound Introducer</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AI091220</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:23:58.470Z</lastUpdated>
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  <row>
    <udiDi>15420045504585</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>ATEC Breast Biopsy and Excision System Ultrasound Introducer</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AI120920</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:23:58.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504592</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>ATEC Breast Biopsy and Excision System Ultrasound Introducer</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AI121220</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:23:58.400Z</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></emdnCode>
    <emdnDescription></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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATEC 0914-20MR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T14:54:40.043Z</lastUpdated>
  </row>
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