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    <basicUdiDi>B-10888385000061</basicUdiDi>
    <tradeName>CellTracks AutoPrep System</tradeName>
    <deviceName>CellTracks AutoPrep System</deviceName>
    <manufacturerName>Menarini Silicon Biosystems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042008</manufacturerSrn>
    <authorisedRepresentativeName>Menarini Silicon Biosystems S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000034891</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9541</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:26:38.711Z</lastUpdated>
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  <row>
    <udiDi>10888385000023</udiDi>
    <basicUdiDi>B-10888385000023</basicUdiDi>
    <tradeName>CellSearch Circulating Tumor Cell (CTC) Control Kit</tradeName>
    <deviceName>CellSearch Circulating Tumor Cell (CTC) Control Kit</deviceName>
    <manufacturerName>Menarini Silicon Biosystems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042008</manufacturerSrn>
    <authorisedRepresentativeName>Menarini Silicon Biosystems S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000034891</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7900003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:26:33.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>10888385000627</udiDi>
    <basicUdiDi>B-10888385000627</basicUdiDi>
    <tradeName>CellTracks Analyzer II</tradeName>
    <deviceName>CellTracks Analyzer II (Refurbished)</deviceName>
    <manufacturerName>Menarini Silicon Biosystems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042008</manufacturerSrn>
    <authorisedRepresentativeName>Menarini Silicon Biosystems S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000034891</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9555R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T08:30:43.030Z</lastUpdated>
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    <udiDi>10888385000030</udiDi>
    <basicUdiDi>B-10888385000030</basicUdiDi>
    <tradeName>CellSave Preservative Tube</tradeName>
    <deviceName>CellSave Preservative Tube (20-Pack)</deviceName>
    <manufacturerName>Menarini Silicon Biosystems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042008</manufacturerSrn>
    <authorisedRepresentativeName>Menarini Silicon Biosystems S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000034891</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>952820</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:58:11.537Z</lastUpdated>
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  <row>
    <udiDi>10888385000610</udiDi>
    <basicUdiDi>B-10888385000610</basicUdiDi>
    <tradeName>CellTracks AutoPrep System</tradeName>
    <deviceName>CellTracks AutoPrep System (Refurbished)</deviceName>
    <manufacturerName>Menarini Silicon Biosystems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042008</manufacturerSrn>
    <authorisedRepresentativeName>Menarini Silicon Biosystems S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000034891</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9541R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:58:09.126Z</lastUpdated>
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  <row>
    <udiDi>10888385000047</udiDi>
    <basicUdiDi>B-10888385000047</basicUdiDi>
    <tradeName>CellSave Preservative Tube</tradeName>
    <deviceName>CellSave Preservative Tube</deviceName>
    <manufacturerName>Menarini Silicon Biosystems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042008</manufacturerSrn>
    <authorisedRepresentativeName>Menarini Silicon Biosystems S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000034891</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7900005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:58:08.451Z</lastUpdated>
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  <row>
    <udiDi>10888385000054</udiDi>
    <basicUdiDi>B-10888385000054</basicUdiDi>
    <tradeName>CellTracks Analyzer II</tradeName>
    <deviceName>CellTracks Analyzer II</deviceName>
    <manufacturerName>Menarini Silicon Biosystems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042008</manufacturerSrn>
    <authorisedRepresentativeName>Menarini Silicon Biosystems S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000034891</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9555</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:41:24.686Z</lastUpdated>
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  <row>
    <udiDi>10888385000016</udiDi>
    <basicUdiDi>B-10888385000016</basicUdiDi>
    <tradeName>CellSearch Circulating Tumor Cell (CTC) Kit</tradeName>
    <deviceName>CellSearch Circulating Tumor Cell (CTC) Kit</deviceName>
    <manufacturerName>Menarini Silicon Biosystems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042008</manufacturerSrn>
    <authorisedRepresentativeName>Menarini Silicon Biosystems S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000034891</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7900001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:41:20.695Z</lastUpdated>
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  <row>
    <udiDi>10888385000078</udiDi>
    <basicUdiDi>088838501003FK</basicUdiDi>
    <tradeName>CELLTRACKS AUTOPREP Instrument Buffer</tradeName>
    <deviceName>CELLTRACKS AUTOPREP Instrument Buffer</deviceName>
    <manufacturerName>Menarini Silicon Biosystems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042008</manufacturerSrn>
    <authorisedRepresentativeName>Menarini Silicon Biosystems S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000034891</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7901003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:02:10.484Z</lastUpdated>
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