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    <udiDi>D-TRMF000028405FVLRT50PC</udiDi>
    <basicUdiDi>B-TRMF000028405FVLRT50PC</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP™ FV Leiden  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>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FVL-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:22:28.755Z</lastUpdated>
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    <udiDi>08595696304287</udiDi>
    <basicUdiDi>B-08595696304287</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Factor V Leiden PCR Kit</tradeName>
    <deviceName>GeneProof Factor V Leiden PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58421</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:27.949Z</lastUpdated>
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    <udiDi>08595696302702</udiDi>
    <basicUdiDi>B-08595696302702</basicUdiDi>
    <tradeName>GeneProof Factor V Leiden MC PCR Kit</tradeName>
    <deviceName>GeneProof Factor V Leiden MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FV/MC/040</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:58.339Z</lastUpdated>
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    <udiDi>08594161958512</udiDi>
    <basicUdiDi>B-08594161958512</basicUdiDi>
    <tradeName>GeneProof Factor V Leiden MC PCR Kit</tradeName>
    <deviceName>GeneProof Factor V Leiden MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FV/MC/200</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:34.607Z</lastUpdated>
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    <udiDi>08594161956976</udiDi>
    <basicUdiDi>B-08594161956976</basicUdiDi>
    <tradeName>GeneProof Factor V Leiden PCR Kit</tradeName>
    <deviceName>GeneProof Factor V Leiden PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FV/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:48.886Z</lastUpdated>
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  <row>
    <udiDi>08594161955023</udiDi>
    <basicUdiDi>B-08594161955023</basicUdiDi>
    <tradeName>GeneProof Factor V Leiden PCR Kit</tradeName>
    <deviceName>GeneProof Factor V Leiden PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FV/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:29.678Z</lastUpdated>
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    <udiDi>08437016942703</udiDi>
    <basicUdiDi>B-08437016942703</basicUdiDi>
    <tradeName>Genvinset® Factor V G1691A 96 tests</tradeName>
    <deviceName>Genvinset® Factor V G1691A 96 tests</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-FV-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:27.013Z</lastUpdated>
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    <udiDi>08437016942383</udiDi>
    <basicUdiDi>B-08437016942383</basicUdiDi>
    <tradeName>Genvinset® Factor V G1691A 48 tests</tradeName>
    <deviceName>Genvinset® Factor V G1691A 48 tests</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-FV-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:53:30.375Z</lastUpdated>
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    <udiDi>08437016942376</udiDi>
    <basicUdiDi>B-08437016942376</basicUdiDi>
    <tradeName>Genvinset® Factor V G1691A 24 tests</tradeName>
    <deviceName>Genvinset® Factor V G1691A 24 tests</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-FV-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:53:29.575Z</lastUpdated>
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    <udiDi>08057723370080</udiDi>
    <basicUdiDi>B-08057723370080</basicUdiDi>
    <tradeName>08057723370080</tradeName>
    <deviceName>SMART SNP 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>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNPD-030</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:35:48.512Z</lastUpdated>
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  <row>
    <udiDi>04050598003125</udiDi>
    <basicUdiDi>B-04050598003125</basicUdiDi>
    <tradeName>MutaREAL® Faktor V</tradeName>
    <deviceName>MutaREAL® Faktor V</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF291796</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:42:32.800Z</lastUpdated>
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    <udiDi>04050598003026</udiDi>
    <basicUdiDi>B-04050598003026</basicUdiDi>
    <tradeName>MutaPLATE® Faktor V</tradeName>
    <deviceName>MutaPLATE® Faktor V</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF1901732</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:42:22.396Z</lastUpdated>
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    <udiDi>04050598002920</udiDi>
    <basicUdiDi>B-04050598002920</basicUdiDi>
    <tradeName>MutaREAL® Factor V</tradeName>
    <deviceName>MutaREAL® Factor V</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF291732</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:42:18.384Z</lastUpdated>
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    <udiDi>04050598002364</udiDi>
    <basicUdiDi>B-04050598002364</basicUdiDi>
    <tradeName>MutaPLATE® Faktor V</tradeName>
    <deviceName>MutaPLATE® Faktor V</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF1901796</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:15.901Z</lastUpdated>
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    <udiDi>04049095160561</udiDi>
    <basicUdiDi>B-04049095160561</basicUdiDi>
    <tradeName>04049095160561</tradeName>
    <deviceName>RIDA®GENE Factor V</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PY1210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:06:30.741Z</lastUpdated>
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    <udiDi>04049055002689</udiDi>
    <basicUdiDi>B-04049055002689</basicUdiDi>
    <tradeName>FluoroType® Factor V VER 1.0</tradeName>
    <deviceName>FluoroType® Factor V VER 1.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60396</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:03:59.411Z</lastUpdated>
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    <udiDi>08906213930511</udiDi>
    <basicUdiDi>89080153043B1321KV</basicUdiDi>
    <tradeName>TRUPCR® Factor II Prothrombin Mutation (G20210A) Detection Kit</tradeName>
    <deviceName>TRUPCR® Factor II Prothrombin Mutation (G20210A) Detection Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1321/C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:03:14.645Z</lastUpdated>
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    <udiDi>08906213930481</udiDi>
    <basicUdiDi>89080153043B1301KP</basicUdiDi>
    <tradeName>TRUPCR® Factor V Leiden Mutation (G1691A) Detection Kit</tradeName>
    <deviceName>TRUPCR® Factor V Leiden Mutation (G1691A) Detection Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1301/C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:03:13.834Z</lastUpdated>
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    <udiDi>08057680910497</udiDi>
    <basicUdiDi>805768091FVG1691_M01CH</basicUdiDi>
    <tradeName>Duplicα RealTime Mix &amp; Match Factor V G1691A Kit QS</tradeName>
    <deviceName>Duplica Real Time Mix &amp; Match FACTOR V G1691A Kit</deviceName>
    <manufacturerName>Clonit srl</manufacturerName>
    <manufacturerSrn>IT-MF-000022196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EER038032QS</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:11:45.099Z</lastUpdated>
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    <udiDi>08057680910015</udiDi>
    <basicUdiDi>805768091FVG1691_M01CH</basicUdiDi>
    <tradeName>Duplica Real Time Mix &amp; Match FACTOR V G1691A Kit</tradeName>
    <deviceName>Duplica Real Time Mix &amp; Match FACTOR V G1691A Kit</deviceName>
    <manufacturerName>Clonit srl</manufacturerName>
    <manufacturerSrn>IT-MF-000022196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EER038032</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:11:43.900Z</lastUpdated>
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