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    <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-36-09</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:25:07.745Z</lastUpdated>
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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>
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    <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>
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    <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>
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  <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>
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  <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>
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    <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>
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    <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>
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  <row>
    <udiDi>15420045509207</udiDi>
    <basicUdiDi>54200455DIAGCOLLECTVT</basicUdiDi>
    <tradeName>Aptima Cervical Specimen Collection and Transport Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050299</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES TRANSPORT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>302657</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T03:41:52.991Z</lastUpdated>
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    <udiDi>15420045511880</udiDi>
    <basicUdiDi>54200455DIAGCOLLECTVT</basicUdiDi>
    <tradeName>Aptima Specimen Transfer Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050299</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES TRANSPORT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-05110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T03:41:52.980Z</lastUpdated>
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  <row>
    <udiDi>25420045506265</udiDi>
    <basicUdiDi>54200455DIAGCOLLECTVT</basicUdiDi>
    <tradeName>Aptima Urine Specimen Collection Kit for Male and Female Urine Specimens</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050299</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES TRANSPORT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T03:41:52.969Z</lastUpdated>
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  <row>
    <udiDi>25420045506272</udiDi>
    <basicUdiDi>54200455DIAGCOLLECTVT</basicUdiDi>
    <tradeName>Aptima Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050299</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES TRANSPORT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301041</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T03:41:52.953Z</lastUpdated>
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    <udiDi>15420045509238</udiDi>
    <basicUdiDi>54200455DIAGCOLLECTVT</basicUdiDi>
    <tradeName>Panther Fusion Specimen Lysis Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050299</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES TRANSPORT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-04339</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T03:41:52.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045513709</udiDi>
    <basicUdiDi>54200455DIAGCOLLECTVT</basicUdiDi>
    <tradeName>Hologic Specimen Lysis Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050299</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES TRANSPORT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-06554</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T03:41:52.871Z</lastUpdated>
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    <udiDi>45420045505781</udiDi>
    <basicUdiDi>54200455MAMMOPADNJ</basicUdiDi>
    <tradeName>MammoPad</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>Z11030285</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:35.638Z</lastUpdated>
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    <udiDi>45420045505798</udiDi>
    <basicUdiDi>54200455MAMMOPADNJ</basicUdiDi>
    <tradeName>MammoPad</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>Z11030285</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:35.570Z</lastUpdated>
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    <udiDi>15420045509337</udiDi>
    <basicUdiDi>54200455DIAGPFPARAFLURZ</basicUdiDi>
    <tradeName>Panther Fusion Paraflu Assay Controls Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-04337</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:34.844Z</lastUpdated>
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    <udiDi>15420045512047</udiDi>
    <basicUdiDi>54200455DIAGAPTBVRB</basicUdiDi>
    <tradeName>Aptima BV 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-05188</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:32.868Z</lastUpdated>
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    <udiDi>15420045512030</udiDi>
    <basicUdiDi>54200455DIAGAPTBVRB</basicUdiDi>
    <tradeName>Aptima BV Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-05186</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:32.852Z</lastUpdated>
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    <udiDi>15420045517059</udiDi>
    <basicUdiDi>54200455DIAGAPTBVRB</basicUdiDi>
    <tradeName>Aptima BV Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-07662</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:32.813Z</lastUpdated>
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