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    <manufacturerName>Cytocell Limited</manufacturerName>
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    <tradeName>Prenatal Enumeration Probe kit</tradeName>
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    <tradeName>Prenatal Enumeration Probe kit</tradeName>
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    <manufacturerName>Cytocell Limited</manufacturerName>
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    <tradeName>Prenatal Enumeration Probe kit</tradeName>
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    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
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    <basicUdiDi>50558449LPA001GG</basicUdiDi>
    <tradeName>Prenatal Enumeration Probe kit</tradeName>
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    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
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    <tradeName>FAST FISH Prenatal Enumeration Probe kit</tradeName>
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    <manufacturerName>Cytocell Limited</manufacturerName>
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    <tradeName>FAST FISH Prenatal Enumeration Probe kit</tradeName>
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    <manufacturerName>Cytocell Limited</manufacturerName>
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    <tradeName>FAST FISH Prenatal Enumeration Probe kit</tradeName>
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    <manufacturerName>Cytocell Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016893</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>SALSA MLPA Probemix P102 HBB</tradeName>
    <deviceName>SALSA MLPA Probemix P102 HBB</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:23:40.896Z</lastUpdated>
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    <tradeName>SALSA MLPA Probemix P102 HBB</tradeName>
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    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>SALSA MLPA Probemix P102 HBB</tradeName>
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    <manufacturerName>MRC Holland B.V.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-27T19:57:49.872Z</lastUpdated>
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    <udiDi>08033629921106</udiDi>
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    <tradeName>08033629921106</tradeName>
    <deviceName>Beta Globin PlusTest</deviceName>
    <manufacturerName>Nuclear Laser Medicine srl</manufacturerName>
    <manufacturerSrn>IT-MF-000025709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC104</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:52:10.434Z</lastUpdated>
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    <basicUdiDi>B-08033629920994</basicUdiDi>
    <tradeName>08033629920994</tradeName>
    <deviceName>Alfa Globin Test</deviceName>
    <manufacturerName>Nuclear Laser Medicine srl</manufacturerName>
    <manufacturerSrn>IT-MF-000025709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <reference>AC099</reference>
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    <lastUpdated>2026-07-24T21:52:09.633Z</lastUpdated>
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    <deviceName>CF PLUS</deviceName>
    <manufacturerName>Nuclear Laser Medicine srl</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceName>CF DEL</deviceName>
    <manufacturerName>Nuclear Laser Medicine srl</manufacturerName>
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    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-22T21:50:02.718Z</lastUpdated>
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