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    <basicUdiDi>42513158D-5601IVDKH</basicUdiDi>
    <tradeName>XA 21q22</tradeName>
    <deviceName>XA 21q22</deviceName>
    <manufacturerName>MetaSystems Probes GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006315</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010301</emdnCode>
    <emdnDescription>DOWN'S SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-5601-100-OR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:57:23.153Z</lastUpdated>
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    <udiDi>05055844906006</udiDi>
    <basicUdiDi>50558449LPA001GG</basicUdiDi>
    <tradeName>Prenatal Enumeration Probe kit</tradeName>
    <deviceName>Prenatal Enumeration Probe kit</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>IVDR 2017/746</legislation>
    <emdnCode>W0106010301</emdnCode>
    <emdnDescription>DOWN'S SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPA 001-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:09:54.282Z</lastUpdated>
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    <udiDi>05055844905986</udiDi>
    <basicUdiDi>50558449LPA001GG</basicUdiDi>
    <tradeName>Prenatal 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>IVDR 2017/746</legislation>
    <emdnCode>W0106010301</emdnCode>
    <emdnDescription>DOWN'S SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPA 001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:08:37.344Z</lastUpdated>
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    <udiDi>05055844905993</udiDi>
    <basicUdiDi>50558449LPA001GG</basicUdiDi>
    <tradeName>Prenatal 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>IVDR 2017/746</legislation>
    <emdnCode>W0106010301</emdnCode>
    <emdnDescription>DOWN'S SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPA 001-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:08:33.388Z</lastUpdated>
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    <udiDi>05055844906013</udiDi>
    <basicUdiDi>50558449LPA001GG</basicUdiDi>
    <tradeName>Prenatal 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>IVDR 2017/746</legislation>
    <emdnCode>W0106010301</emdnCode>
    <emdnDescription>DOWN'S SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE-LPA 001-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:07:23.905Z</lastUpdated>
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    <udiDi>D-CY-MF-0000093819M</udiDi>
    <basicUdiDi>B-CY-MF-0000093819M</basicUdiDi>
    <tradeName>VERACITY &amp; VERACITY HC IVD kit reagents and VEGA software</tradeName>
    <deviceName>VERACITY IVD KIT REAGENTS for 48 samples</deviceName>
    <manufacturerName>MEDICOVER GENETICS LIMITED</manufacturerName>
    <manufacturerSrn>CY-MF-000009381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010301</emdnCode>
    <emdnDescription>DOWN'S SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV100-00-248</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-13T10:39:30.563Z</lastUpdated>
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    <udiDi>07350041434603</udiDi>
    <basicUdiDi>B-07350041434603</basicUdiDi>
    <tradeName>07350041434603</tradeName>
    <deviceName>ChromoQuant Optima 21</deviceName>
    <manufacturerName>Cybergene AB</manufacturerName>
    <manufacturerSrn>SE-MF-000054343</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010301</emdnCode>
    <emdnDescription>DOWN'S SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514.603-26</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:14:12.460Z</lastUpdated>
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