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    <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_0913-12T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.941Z</lastUpdated>
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    <udiDi>15420045505438</udiDi>
    <basicUdiDi>54200455DIAGAPTGCQL</basicUdiDi>
    <tradeName>Aptima Neisseria gonorrhoeae</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>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>302927</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.887Z</lastUpdated>
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    <udiDi>15420045505490</udiDi>
    <basicUdiDi>54200455DIAGAPTTRICHWY</basicUdiDi>
    <tradeName>Aptima Trichomonas vaginalis 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>IVDR 2017/746</legislation>
    <emdnCode>W0105050310</emdnCode>
    <emdnDescription>TRICHOMONAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303163</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.845Z</lastUpdated>
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    <basicUdiDi>54200455DIAGAPTTRICHWY</basicUdiDi>
    <tradeName>Aptima Trichomonas vaginalis 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>IVDR 2017/746</legislation>
    <emdnCode>W0105050310</emdnCode>
    <emdnDescription>TRICHOMONAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303209</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.823Z</lastUpdated>
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    <udiDi>15420045505513</udiDi>
    <basicUdiDi>54200455DIAGAPTTRICHWY</basicUdiDi>
    <tradeName>Aptima Trichomonas vaginalis 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>IVDR 2017/746</legislation>
    <emdnCode>W0105050310</emdnCode>
    <emdnDescription>TRICHOMONAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303209</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.798Z</lastUpdated>
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    <udiDi>15420045505766</udiDi>
    <basicUdiDi>54200455DIAGAPTTRICHWY</basicUdiDi>
    <tradeName>Aptima Trichomonas vaginalis 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>IVDR 2017/746</legislation>
    <emdnCode>W0105050310</emdnCode>
    <emdnDescription>TRICHOMONAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>302807</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.773Z</lastUpdated>
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    <udiDi>15420045507227</udiDi>
    <basicUdiDi>54200455DIAGAPTHSV12S7</basicUdiDi>
    <tradeName>Aptima Herpes Simplex Viruses 1 &amp; 2 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>IVDR 2017/746</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-03568</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.718Z</lastUpdated>
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    <udiDi>15420045507234</udiDi>
    <basicUdiDi>54200455DIAGAPTHSV12S7</basicUdiDi>
    <tradeName>Aptima Herpes Simplex Viruses 1 &amp; 2 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>IVDR 2017/746</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-03569</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.692Z</lastUpdated>
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    <udiDi>15420045507401</udiDi>
    <basicUdiDi>B-15420045507401</basicUdiDi>
    <tradeName>Fluent Fluid Management System Disposable Procedure Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003310</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>FLT-112S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.673Z</lastUpdated>
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    <udiDi>15420045507654</udiDi>
    <basicUdiDi>54200455GSSMYOSURETRDQK</basicUdiDi>
    <tradeName>MyoSure XL Tissue Removal Device for Fluent</tradeName>
    <deviceName></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>Z12080204</emdnCode>
    <emdnDescription>MORCELLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50-601XL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.639Z</lastUpdated>
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    <udiDi>15420045507753</udiDi>
    <basicUdiDi>54200455BREVERASYSTA</basicUdiDi>
    <tradeName>Brevera Breast Biopsy System with CorLumina Imaging Technology</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>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>BREV200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.620Z</lastUpdated>
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    <udiDi>15420045507807</udiDi>
    <basicUdiDi>54200455BREVERASYSTA</basicUdiDi>
    <tradeName>Brevera Breast Biopsy System Adapter</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>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>BREVADPTR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.601Z</lastUpdated>
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    <udiDi>15420045507821</udiDi>
    <basicUdiDi>54200455BREVERASYSTA</basicUdiDi>
    <tradeName>Brevera Breast Biopsy System Stylet Bracket</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>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>BREVSTYLBRKT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.584Z</lastUpdated>
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    <udiDi>15420045507838</udiDi>
    <basicUdiDi>54200455BREVERASYSTA</basicUdiDi>
    <tradeName>Brevera Breast Biopsy System Adapter for MammoTest</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>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>BREVADPTRM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.569Z</lastUpdated>
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    <udiDi>15420045507852</udiDi>
    <basicUdiDi>54200455BREVERASYSTA</basicUdiDi>
    <tradeName>Brevera Breast Biopsy System Adapter for GE Senographe Stereotaxy</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>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>BREVADPTRG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.547Z</lastUpdated>
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    <udiDi>15420045508552</udiDi>
    <basicUdiDi>B-15420045508552</basicUdiDi>
    <tradeName>Fluent Fluid Management System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003310</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLT-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.451Z</lastUpdated>
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    <udiDi>15420045509153</udiDi>
    <basicUdiDi>54200455DIAGAPTMGENY9</basicUdiDi>
    <tradeName>Aptima Mycoplasma genitalium 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>IVDR 2017/746</legislation>
    <emdnCode>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-03374</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.425Z</lastUpdated>
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    <udiDi>15420045509313</udiDi>
    <basicUdiDi>54200455DIAGPFFLUABRSVWG</basicUdiDi>
    <tradeName>Panther Fusion Flu A/B/RSV 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-04336</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.335Z</lastUpdated>
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    <basicUdiDi>54200455DIAGPFAdVhMPVRVZ2</basicUdiDi>
    <tradeName>Panther Fusion AdV/hMPV/RV 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>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-04338</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.308Z</lastUpdated>
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    <udiDi>15420045509559</udiDi>
    <basicUdiDi>54200455DIAGAPTHPVBR</basicUdiDi>
    <tradeName>Aptima HPV 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>IVDR 2017/746</legislation>
    <emdnCode>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>302929</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:17.020Z</lastUpdated>
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