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    <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>303093</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:16.993Z</lastUpdated>
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    <basicUdiDi>54200455DIAGAPTHPVBR</basicUdiDi>
    <tradeName>Aptima HPV Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>303093</reference>
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    <udiDi>15420045510449</udiDi>
    <basicUdiDi>54200455DIAGPFMRSADE</basicUdiDi>
    <tradeName>Panther Fusion MRSA Assay Controls</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>W0105011203</emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-04805</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <basicUdiDi>54200455DIAGAPTCVTV2E</basicUdiDi>
    <tradeName>Aptima CV/TV 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>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></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:16.653Z</lastUpdated>
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    <udiDi>15420045512092</udiDi>
    <basicUdiDi>54200455DIAGAPTCVTV2E</basicUdiDi>
    <tradeName>Aptima CV/TV 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>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-05190</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:16.611Z</lastUpdated>
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    <udiDi>15420045517073</udiDi>
    <basicUdiDi>54200455DIAGAPTCVTV2E</basicUdiDi>
    <tradeName>Aptima CV/TV 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>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-07665</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:16.131Z</lastUpdated>
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    <basicUdiDi>54200455DIAGAPTCVTV2E</basicUdiDi>
    <tradeName>Aptima CV/TV 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>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-07665</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:22:16.103Z</lastUpdated>
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    <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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    <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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    <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>
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    <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>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>
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    <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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    <udiDi>15420045512054</udiDi>
    <basicUdiDi>54200455DIAGAPTBVRB</basicUdiDi>
    <tradeName>Aptima BV Assay Controls Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-05187</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:32.791Z</lastUpdated>
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    <basicUdiDi>54200455DIAGAPTBVRB</basicUdiDi>
    <tradeName>Aptima BV Assay</tradeName>
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    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
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    <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>2026-06-23T19:31:32.766Z</lastUpdated>
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    <udiDi>15420045506244</udiDi>
    <basicUdiDi>54200455DIAGCOLLECTVT</basicUdiDi>
    <tradeName>Aptima Urine Specimen Transport Tubes</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>105575</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:32.100Z</lastUpdated>
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