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<eudamedExport entity="devices">
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    <basicUdiDi>54200455TRUNODEBSHD6</basicUdiDi>
    <tradeName>TruNode Single-Use Gamma Probe</tradeName>
    <deviceName>TruNode Gamma Probe System</deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045852</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11029001</emdnCode>
    <emdnDescription>BETA/GAMMA DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120-807605</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:30.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045507517</udiDi>
    <basicUdiDi>54200455BREVERASYSTA</basicUdiDi>
    <tradeName>Brevera Breast Biopsy System with CorLumina Imaging Technology</tradeName>
    <deviceName>Brevera Breast Biopsy System</deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045852</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01020199</emdnCode>
    <emdnDescription>NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BREV100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:05:50.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045503182</udiDi>
    <basicUdiDi>54200455ATECEVIVACCESS8K</basicUdiDi>
    <tradeName>ATEC Canister</tradeName>
    <deviceName>ATEC and Eviva Breast Biopsy and Excision System</deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045852</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010299</emdnCode>
    <emdnDescription>BIOPSY NEEDLES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATEC Canister</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:05:37.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420045503277</udiDi>
    <basicUdiDi>54200455TRIMARKBSH5X</basicUdiDi>
    <tradeName>ATEC TriMark Titanium Biopsy Site Marker</tradeName>
    <deviceName>TriMark Biopsy Site Markers</deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045852</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRIMARK TD 1309</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:04:22.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420045503192</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>ATEC Breast Biopsy and Excision System Introducer Localization System</tradeName>
    <deviceName>ATEC and Eviva Breast Biopsy and Excision System - Biopsy Devices and Introducers</deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045852</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEEDLE INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILS 0914-12</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:04:21.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420045503109</udiDi>
    <basicUdiDi>54200455BRSTSNGTFGK</basicUdiDi>
    <tradeName>ATEC Breast Biopsy and Excision System Needle Guide</tradeName>
    <deviceName>ATEC and Eviva Breast Biopsy and Excision System - Needle Guides and Tissue Filter</deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045852</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEEDLE GUIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATEC NG09-LORAD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:04:20.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504608</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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVIVA_NG09R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504615</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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVIVA_NG12R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504837</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>ATEC 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 0909-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504844</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>ATEC 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 0909-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504851</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>ATEC 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 0912-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504868</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>ATEC 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 0912-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504882</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>ATEC 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 0914-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504905</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>ATEC 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 1209-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504912</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>ATEC 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 1212-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504936</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>Eviva Stereotactic Guided Breast Biopsy System Biopsy Device</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>EVIVA_0910-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504943</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>Eviva Stereotactic Guided Breast Biopsy System Biopsy Device</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>EVIVA_0910-12T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504950</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>Eviva Stereotactic Guided Breast Biopsy System Biopsy Device</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>EVIVA_0910-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504974</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>Eviva Stereotactic Guided Breast Biopsy System Biopsy Device</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>EVIVA_0913-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045504981</udiDi>
    <basicUdiDi>54200455ATECEVIVAHANDPCHA</basicUdiDi>
    <tradeName>Eviva Stereotactic Guided Breast Biopsy System Biopsy Device</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>EVIVA_1210-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.056Z</lastUpdated>
  </row>
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