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    <tradeName>HemosIL CL HIT-IgG(PF4-H)</tradeName>
    <deviceName>HemosIL CL HIT-IgG(PF4-H)</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020402</emdnCode>
    <emdnDescription>PLATELET FACTOR 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029706200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:05:32.795Z</lastUpdated>
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    <udiDi>03607450009514</udiDi>
    <basicUdiDi>B-03607450009514</basicUdiDi>
    <tradeName>Asserachrom® PF4</tradeName>
    <deviceName>Asserachrom® PF4</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020402</emdnCode>
    <emdnDescription>PLATELET FACTOR 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00951</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:58:56.261Z</lastUpdated>
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    <udiDi>10888234500421</udiDi>
    <basicUdiDi>88823411W0103020402C01DUK</basicUdiDi>
    <tradeName>PF4 Concentrated Wash</tradeName>
    <deviceName>PF4 Concentrated Wash</deviceName>
    <manufacturerName>Immucor GTI Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000020921</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020402</emdnCode>
    <emdnDescription>PLATELET FACTOR 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403624</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:10:07.498Z</lastUpdated>
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    <udiDi>10888234500353</udiDi>
    <basicUdiDi>88823411W0103020402C01CUH</basicUdiDi>
    <tradeName>Specimen Diluent</tradeName>
    <deviceName>Specimen Diluent</deviceName>
    <manufacturerName>Immucor GTI Diagnostics, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000020921</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020402</emdnCode>
    <emdnDescription>PLATELET FACTOR 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403602</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:52.242Z</lastUpdated>
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  <row>
    <udiDi>08426950545774</udiDi>
    <basicUdiDi>84269505457749A</basicUdiDi>
    <tradeName>HemosIL AcuStar HIT-IgG(PF4-H)</tradeName>
    <deviceName>HemosIL AcuStar HIT-IgG(PF4-H)</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020402</emdnCode>
    <emdnDescription>PLATELET FACTOR 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009802028</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:06:12.448Z</lastUpdated>
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