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    <tradeName>Aptima Combo 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>
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    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-05576</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:47:58.307Z</lastUpdated>
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    <basicUdiDi>54200455DIAGAPTHPVGTVK</basicUdiDi>
    <tradeName>Aptima HPV 16 18/45 Genotype Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303236</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.474Z</lastUpdated>
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    <tradeName>Eviva Needle Guide</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic, Inc.</manufacturerName>
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    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVIVA_NG09R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.370Z</lastUpdated>
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    <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>
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    <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>
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    <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>
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    <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>
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    <udiDi>15420045504868</udiDi>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <udiDi>15420045504998</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>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVIVA_1213-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.038Z</lastUpdated>
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    <udiDi>15420045505070</udiDi>
    <basicUdiDi>54200455GSSMYOSURETRDQK</basicUdiDi>
    <tradeName>MyoSure LITE Tissue Removal Device</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>30-401LITE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.021Z</lastUpdated>
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    <basicUdiDi>54200455GSSMYOSURETRDQK</basicUdiDi>
    <tradeName>MyoSure XL Tissue Removal Device</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>50-501XL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:24.008Z</lastUpdated>
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    <udiDi>15420045505322</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_0913-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:23.969Z</lastUpdated>
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