<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>15420045512917</udiDi>
    <basicUdiDi>54200455DIAGFLUIDSBG</basicUdiDi>
    <tradeName>Panther Fusion Extraction Reagent-B</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-06232</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:32:59.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045517486</udiDi>
    <basicUdiDi>54200455DIAGPFGIBACUY</basicUdiDi>
    <tradeName>Panther Fusion GI Bacterial Assay</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-07113</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:32:56.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045517493</udiDi>
    <basicUdiDi>54200455DIAGPFGIBACUY</basicUdiDi>
    <tradeName>Panther Fusion GI Bacterial 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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-07116</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:32:56.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045517509</udiDi>
    <basicUdiDi>54200455DIAGPFGIEXPBACUK</basicUdiDi>
    <tradeName>Panther Fusion GI Expanded Bacterial Assay</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-07121</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:32:56.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045517516</udiDi>
    <basicUdiDi>54200455DIAGPFGIEXPBACUK</basicUdiDi>
    <tradeName>Panther Fusion GI Expanded Bacterial 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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-07122</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:32:56.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045513938</udiDi>
    <basicUdiDi>54200455CYTCELLIENTNX</basicUdiDi>
    <tradeName>Cellient Automated Cell Block System Filter Cassette Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001677</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>71305-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:32:49.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045508569</udiDi>
    <basicUdiDi>54200455CYTCELLIENTNX</basicUdiDi>
    <tradeName>Cellient Automated Cell Block System Processor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001677</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>71959-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:32:48.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045508576</udiDi>
    <basicUdiDi>54200455CYTCELLIENTNX</basicUdiDi>
    <tradeName>Cellient Automated Cell Block System Finishing Station</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001677</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>71664-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:32:48.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>45420045505668</udiDi>
    <basicUdiDi>54200455MAMMOPADNJ</basicUdiDi>
    <tradeName>MammoPad</tradeName>
    <deviceName>MammoPad</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>MP101</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:48.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>25420045505275</udiDi>
    <basicUdiDi>54200455GSSFLUENTMULTIH7</basicUdiDi>
    <tradeName>Fluent Fluid Management System Tissue Trap</tradeName>
    <deviceName>Fluent Fluid Management System Waste Bag; Fluent Fluid Management System Tissue Trap; Fluent Pro Fluid Management System Waste Bag; Fluent Pro Fluid Management System Tissue Trap</deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003310</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A080299</emdnCode>
    <emdnDescription>INFUSION BAGS AND CONTAINERS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLT-010</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:47.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045516595</udiDi>
    <basicUdiDi>54200455GSSSCOPETRAYZR</basicUdiDi>
    <tradeName>Omni Instrument Tray</tradeName>
    <deviceName>Omni Instrument Tray</deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003310</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S010401</emdnCode>
    <emdnDescription>TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60-903-1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:38.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045516212</udiDi>
    <basicUdiDi>54200455GSSFLUENTSYSZL</basicUdiDi>
    <tradeName>Fluent Pro Fluid Management System</tradeName>
    <deviceName>Fluent Pro Fluid Management System</deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003310</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030301</emdnCode>
    <emdnDescription>INFUSION PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLT-200</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:37.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045516144</udiDi>
    <basicUdiDi>54200455GSSFLUENTDISPZN</basicUdiDi>
    <tradeName>Fluent Pro Fluid Management System Procedure Kit</tradeName>
    <deviceName>Fluent Pro Fluid Management System Disposable Procedure Kit</deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003310</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A080201</emdnCode>
    <emdnDescription>INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLT-212S</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:36.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045514577</udiDi>
    <basicUdiDi>54200455DIAGAPTCMVAP</basicUdiDi>
    <tradeName>Aptima CMV Quant Assay Calibrator</tradeName>
    <deviceName>Aptima CMV Quant Assay</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>W0105080908</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-05075</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:35.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045514218</udiDi>
    <basicUdiDi>54200455FAXITRONCABXRAYBU</basicUdiDi>
    <tradeName>Faxitron Core Specimen Radiography System</tradeName>
    <deviceName>Faxitron Radiography System</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>COREVISION5X10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:31.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045512856</udiDi>
    <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>15420045512832</udiDi>
    <basicUdiDi>54200455DIAGAPTCOMBO2P8</basicUdiDi>
    <tradeName>Aptima Combo 2 Assay</tradeName>
    <deviceName>Aptima Combo 2 Assay</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-05571</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:30.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045512214</udiDi>
    <basicUdiDi>54200455TRIDENTHDDN</basicUdiDi>
    <tradeName>Trident HD Specimen Radiography System</tradeName>
    <deviceName>Trident® HD Specimen Radiography System</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>TRI-00002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:29.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045512191</udiDi>
    <basicUdiDi>54200455GSSSCOPESEALWP</basicUdiDi>
    <tradeName>Omni Lok Cervical Seal</tradeName>
    <deviceName>Omni Lok Cervical Seal; Omni 5Fr Seal Cap; MyoSure Single Use Seal</deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003310</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020785</emdnCode>
    <emdnDescription>GENITOURINARY ENDOSCOPY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OLK-100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:25.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045512061</udiDi>
    <basicUdiDi>54200455DIAGAPTCVTV2E</basicUdiDi>
    <tradeName>Aptima CV/TV Assay</tradeName>
    <deviceName>Aptima CV/TV Assay</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-05189</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:24.565Z</lastUpdated>
  </row>
</eudamedExport>