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    <basicUdiDi>B-07332940000240</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® FII &amp; FV</deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010115</emdnCode>
    <emdnDescription>COMBINED FACTOR II / FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXFIIFV-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:55:10.403Z</lastUpdated>
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    <udiDi>D-TRMF000028405THRRT50T6</udiDi>
    <basicUdiDi>B-TRMF000028405THRRT50T6</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP FXIII Mutation Detection Kit, 50T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010115</emdnCode>
    <emdnDescription>COMBINED FACTOR II / FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THR-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:23:36.558Z</lastUpdated>
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    <udiDi>D-TRMF000028405THR6RT50HP</udiDi>
    <basicUdiDi>B-TRMF000028405THR6RT50HP</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP Thrombophilia P., 50T (FII, FVL,MTHFR677, MTHFR1298, PAI,FXIII)</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010115</emdnCode>
    <emdnDescription>COMBINED FACTOR II / FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THR6-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:23:35.873Z</lastUpdated>
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    <udiDi>D-84295773117WMFQ</udiDi>
    <basicUdiDi>B-84295773117WMFQ</basicUdiDi>
    <tradeName>ThromboSrip</tradeName>
    <deviceName>ThromboStrip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010115</emdnCode>
    <emdnDescription>COMBINED FACTOR II / FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.117.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:18.126Z</lastUpdated>
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    <udiDi>08057723370110</udiDi>
    <basicUdiDi>B-08057723370110</basicUdiDi>
    <tradeName>08057723370110</tradeName>
    <deviceName>SMART SNP FII FVL Direct Kit</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010115</emdnCode>
    <emdnDescription>COMBINED FACTOR II / FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNPD-034</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:35:54.927Z</lastUpdated>
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    <udiDi>04049055001125</udiDi>
    <basicUdiDi>B-04049055001125</basicUdiDi>
    <tradeName>ThromboType® VER 2.0</tradeName>
    <deviceName>ThromboType® VER 2.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010115</emdnCode>
    <emdnDescription>COMBINED FACTOR II / FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24196</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:03:52.205Z</lastUpdated>
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    <udiDi>04049055001118</udiDi>
    <basicUdiDi>B-04049055001118</basicUdiDi>
    <tradeName>ThromboType® VER 2.0</tradeName>
    <deviceName>ThromboType® VER 2.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010115</emdnCode>
    <emdnDescription>COMBINED FACTOR II / FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>241</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:03:48.220Z</lastUpdated>
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    <udiDi>03760322820102</udiDi>
    <basicUdiDi>376032282CGENF2F5FW</basicUdiDi>
    <tradeName>ThromboGUARD FII FV</tradeName>
    <deviceName>ThromboGUARD FII FV</deviceName>
    <manufacturerName>APPOLON BIOTECK</manufacturerName>
    <manufacturerSrn>FR-MF-000022234</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010115</emdnCode>
    <emdnDescription>COMBINED FACTOR II / FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0023</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:25:31.674Z</lastUpdated>
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    <udiDi>08028169208404</udiDi>
    <basicUdiDi>802816920CW01060402045C</basicUdiDi>
    <tradeName>Eu-Gen FII/FV Type (25 T)</tradeName>
    <deviceName>Eu-Gen FII/FV Type</deviceName>
    <manufacturerName>Eurospital Spa</manufacturerName>
    <manufacturerSrn>IT-MF-000028468</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010115</emdnCode>
    <emdnDescription>COMBINED FACTOR II / FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9462S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:24:23.191Z</lastUpdated>
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    <udiDi>08028169208275</udiDi>
    <basicUdiDi>802816920CW01060402045C</basicUdiDi>
    <tradeName>Eu-Gen FII/FV Type</tradeName>
    <deviceName>Eu-Gen FII/FV Type</deviceName>
    <manufacturerName>Eurospital Spa</manufacturerName>
    <manufacturerSrn>IT-MF-000028468</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010115</emdnCode>
    <emdnDescription>COMBINED FACTOR II / FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9462</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:24:22.303Z</lastUpdated>
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    <udiDi>03760322820157</udiDi>
    <basicUdiDi>376032282CGENF2F5FW</basicUdiDi>
    <tradeName>ThromboGUARD FII FV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APPOLON BIOTECK</manufacturerName>
    <manufacturerSrn>FR-MF-000022234</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010115</emdnCode>
    <emdnDescription>COMBINED FACTOR II / FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:00:28.395Z</lastUpdated>
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