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    <manufacturerName>New Erie Scientific LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008165</manufacturerSrn>
    <authorisedRepresentativeName>Epredia Netherlands B.V.</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Cover Slips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>New Erie Scientific LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008165</manufacturerSrn>
    <authorisedRepresentativeName>Epredia Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001488</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CB00120RAC20MNZ0</reference>
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    <tradeName>Cover Slips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>New Erie Scientific LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008165</manufacturerSrn>
    <authorisedRepresentativeName>Epredia Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001488</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>W0503900202</emdnCode>
    <emdnDescription>MICROSCOPE SLIDES COVERSLIP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB02100260A113MNZ0</reference>
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    <udiDi>06974570460110</udiDi>
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    <tradeName>DiaTrust</tradeName>
    <deviceName>Microscope Slide</deviceName>
    <manufacturerName>DiaTrust Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009279</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>MICROSCOPE SLIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B101-1001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
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    <tradeName>Microscope Cover Glass</tradeName>
    <deviceName>Microscope Cover Glass</deviceName>
    <manufacturerName>Boen Healthcare Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000040773</manufacturerSrn>
    <authorisedRepresentativeName>Everbiz GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000035279</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503900202</emdnCode>
    <emdnDescription>MICROSCOPE SLIDES COVERSLIP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>620810</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:28:09.393Z</lastUpdated>
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    <deviceName>Microscope Slide</deviceName>
    <manufacturerName>Boen Healthcare Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000040773</manufacturerSrn>
    <authorisedRepresentativeName>Everbiz GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000035279</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503900201</emdnCode>
    <emdnDescription>MICROSCOPE SLIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7105</reference>
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    <lastUpdated>2026-07-16T07:28:07.994Z</lastUpdated>
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    <tradeName>Knittel Glass Starfrost Microscope Slides</tradeName>
    <deviceName>Microscope slides</deviceName>
    <manufacturerName>Waldemar Knittel Glasbearbeitungs GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005025</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503900201</emdnCode>
    <emdnDescription>MICROSCOPE SLIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F/STF-BR-BL-1000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:41:49.595Z</lastUpdated>
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    <tradeName>Knittel Glass Cover Glass</tradeName>
    <deviceName>coverglass</deviceName>
    <manufacturerName>Waldemar Knittel Glasbearbeitungs GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005025</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503900202</emdnCode>
    <emdnDescription>MICROSCOPE SLIDES COVERSLIP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JKHP2460</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:41:49.127Z</lastUpdated>
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    <udiDi>20888937025839</udiDi>
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    <tradeName>HBA®</tradeName>
    <deviceName>HBA® Sperm-Hyaluronan Binding Assay</deviceName>
    <manufacturerName>CooperSurgical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002607</manufacturerSrn>
    <authorisedRepresentativeName>CooperSurgical Distribution B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000059</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCT-HBA-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:45:37.645Z</lastUpdated>
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    <tradeName>Cell-VU Microscope Slides and Coverslips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MILLENNIUM SCIENCES, INC</manufacturerName>
    <manufacturerSrn>US-MF-000024011</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503900201</emdnCode>
    <emdnDescription>MICROSCOPE SLIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRM-600</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:00:02.358Z</lastUpdated>
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    <tradeName>ClearPrep</tradeName>
    <deviceName>Clear Prep Cytology System</deviceName>
    <manufacturerName>Resolution Biomedical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029623</manufacturerSrn>
    <authorisedRepresentativeName>Cost Saving Solutions Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000016085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP11006</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:29:31.218Z</lastUpdated>
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    <tradeName>MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit</tradeName>
    <deviceName>MammaPrint BluePrint NGS Kit</deviceName>
    <manufacturerName>Agendia N.V</manufacturerName>
    <manufacturerSrn>NL-MF-000011684</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>931280</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:20:53.536Z</lastUpdated>
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    <deviceName>BluePrint Diagnostic Microarray</deviceName>
    <manufacturerName>Agendia N.V</manufacturerName>
    <manufacturerSrn>NL-MF-000011684</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05039099</emdnCode>
    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA (Centralized Lab Product)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:20:52.730Z</lastUpdated>
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    <tradeName>MammaPrint FFPE microarray</tradeName>
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    <manufacturerName>Agendia N.V</manufacturerName>
    <manufacturerSrn>NL-MF-000011684</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA (Centralized Lab Product)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:20:51.130Z</lastUpdated>
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    <tradeName>Streck</tradeName>
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    <manufacturerSrn>US-MF-000013009</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>230200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:20:45.423Z</lastUpdated>
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    <manufacturerSrn>US-MF-000013009</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>DEVICES FOR SAMPLES ANALYSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>230202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:20:42.881Z</lastUpdated>
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    <tradeName>SlideMate™ Plus Adhesion Microscope Slides</tradeName>
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    <manufacturerName>New Erie Scientific LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008165</manufacturerSrn>
    <authorisedRepresentativeName>Epredia Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001488</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503900201</emdnCode>
    <emdnDescription>MICROSCOPE SLIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TT-40418218-PS-W</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:38:42.691Z</lastUpdated>
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