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    <deviceName>Prenatal 13 and 21 Enumeration Probe kit</deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
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    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010304</emdnCode>
    <emdnDescription>PÄTAU SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPA 003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:18:03.751Z</lastUpdated>
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    <udiDi>07350041434580</udiDi>
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    <tradeName>07350041434580</tradeName>
    <deviceName>ChromoQuant Optima 13</deviceName>
    <manufacturerName>Cybergene AB</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010304</emdnCode>
    <emdnDescription>PÄTAU SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514.601-26</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:14:10.850Z</lastUpdated>
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    <basicUdiDi>50558449LPA003GL</basicUdiDi>
    <tradeName>Prenatal 13 and 21 Enumeration Probe kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>DOWN'S SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPA 003-S</reference>
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    <lastUpdated>2026-06-27T18:20:56.975Z</lastUpdated>
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    <basicUdiDi>50558449LPA003GL</basicUdiDi>
    <tradeName>Prenatal 13 and 21 Enumeration Probe kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010304</emdnCode>
    <emdnDescription>DOWN'S SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPA 003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:56.036Z</lastUpdated>
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    <basicUdiDi>50558449LPA003GL</basicUdiDi>
    <tradeName>Prenatal 13 and 21 Enumeration Probe kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010304</emdnCode>
    <emdnDescription>DOWN'S SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPA 003-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:56.018Z</lastUpdated>
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