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    <tradeName>Yourgene® Cystic Fibrosis Base</tradeName>
    <deviceName>Yourgene® Cystic Fibrosis</deviceName>
    <manufacturerName>Yourgene Health UK Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000024810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
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    <udiDi>08033629920871</udiDi>
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    <deviceName>CF PLUS</deviceName>
    <manufacturerName>Nuclear Laser Medicine srl</manufacturerName>
    <manufacturerSrn>IT-MF-000025709</manufacturerSrn>
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    <reference>AC089</reference>
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    <basicUdiDi>B-08033629920345</basicUdiDi>
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    <deviceName>CF DEL</deviceName>
    <manufacturerName>Nuclear Laser Medicine srl</manufacturerName>
    <manufacturerSrn>IT-MF-000025709</manufacturerSrn>
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    <udiDi>08033629924473</udiDi>
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    <deviceName>CF FAST</deviceName>
    <manufacturerName>Nuclear Laser Medicine srl</manufacturerName>
    <manufacturerSrn>IT-MF-000025709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA1358/48A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:47:04.254Z</lastUpdated>
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    <udiDi>00816270020149</udiDi>
    <basicUdiDi>0081627002CYSTFIB8C</basicUdiDi>
    <tradeName>TruSight™ Cystic Fibrosis Library Prep</tradeName>
    <deviceName>TruSight™ Cystic Fibrosis</deviceName>
    <manufacturerName>Illumina, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013476</manufacturerSrn>
    <authorisedRepresentativeName>Illumina Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000012614</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20036925</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:22:41.713Z</lastUpdated>
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    <udiDi>D-9018BH</udiDi>
    <basicUdiDi>B-9018BH</basicUdiDi>
    <tradeName>D-9018BH</tradeName>
    <deviceName>Cystic Fibrosis Transmembrane Conductance Regulator Gene (CFTR) Library Prep Kit for Illumina®</deviceName>
    <manufacturerName>NimaGen BV</manufacturerName>
    <manufacturerSrn>NL-MF-000022926</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RC-CFTR096-I</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:55:00.511Z</lastUpdated>
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    <udiDi>D-9017BF</udiDi>
    <basicUdiDi>B-9017BF</basicUdiDi>
    <tradeName>D-9017BF</tradeName>
    <deviceName>Cystic Fibrosis Transmembrane Conductance Regulator Gene (CFTR) Mutation Hotspots Library Prep Kit for Illumina®</deviceName>
    <manufacturerName>NimaGen BV</manufacturerName>
    <manufacturerSrn>NL-MF-000022926</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RC-CFHS096-I</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:54:55.381Z</lastUpdated>
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    <udiDi>08437016942901</udiDi>
    <basicUdiDi>B-08437016942901</basicUdiDi>
    <tradeName>Genvinset® deltaF508 96 tests</tradeName>
    <deviceName>Genvinset® deltaF508 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>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-DF508-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:40.616Z</lastUpdated>
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    <udiDi>08437016942895</udiDi>
    <basicUdiDi>B-08437016942895</basicUdiDi>
    <tradeName>Genvinset® deltaF508 48 tests</tradeName>
    <deviceName>Genvinset® deltaF508 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>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-DF508-48</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:39.816Z</lastUpdated>
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    <udiDi>08437016942888</udiDi>
    <basicUdiDi>B-08437016942888</basicUdiDi>
    <tradeName>Genvinset® deltaF508 24 tests</tradeName>
    <deviceName>Genvinset® deltaF508 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>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-DF508-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:55:35.951Z</lastUpdated>
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    <udiDi>08033629920321</udiDi>
    <basicUdiDi>B-08033629920321</basicUdiDi>
    <tradeName>08033629920321</tradeName>
    <deviceName>Cystic Fibrosis</deviceName>
    <manufacturerName>Nuclear Laser Medicine srl</manufacturerName>
    <manufacturerSrn>IT-MF-000025709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC023/25</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T09:14:16.242Z</lastUpdated>
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    <udiDi>07350040630648</udiDi>
    <basicUdiDi>B-07350040630648</basicUdiDi>
    <tradeName>Devyser CFTR 68</tradeName>
    <deviceName>Devyser CFTR 68</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A045</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:20.361Z</lastUpdated>
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    <udiDi>07350040630624</udiDi>
    <basicUdiDi>B-07350040630624</basicUdiDi>
    <tradeName>Devyser CFTR 68</tradeName>
    <deviceName>Devyser CFTR 68</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A045-8</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:19.561Z</lastUpdated>
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    <udiDi>07350040630617</udiDi>
    <basicUdiDi>B-07350040630617</basicUdiDi>
    <tradeName>Devyser CFTR 68</tradeName>
    <deviceName>Devyser CFTR 68</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A045-24</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:17.977Z</lastUpdated>
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    <udiDi>06974968584022</udiDi>
    <basicUdiDi>B-06974968584022</basicUdiDi>
    <tradeName>GeneMind</tradeName>
    <deviceName>Cystic Fibrosis Detection Kit Based On Whole Exome Sequencing Technology (Sequencing Method)</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L000154</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:08:08.221Z</lastUpdated>
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    <udiDi>06974968583568</udiDi>
    <basicUdiDi>B-06974968583568</basicUdiDi>
    <tradeName>GeneMind</tradeName>
    <deviceName>Cystic Fibrosis Detection Kit (Sequencing Method)</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <emdnCode>W0106010101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>L000106</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:08:05.812Z</lastUpdated>
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    <udiDi>04050598010833</udiDi>
    <basicUdiDi>B-04050598010833</basicUdiDi>
    <tradeName>MutaREAL® Cystic Fibrosis</tradeName>
    <deviceName>MutaREAL® Cystic Fibrosis</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF290832</reference>
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    <lastUpdated>2026-07-06T00:49:20.587Z</lastUpdated>
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    <basicUdiDi>B-04050598010826</basicUdiDi>
    <tradeName>MutaREAL® Cystic Fibrosis</tradeName>
    <deviceName>MutaREAL® Cystic Fibrosis</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>MutaPLATE® Cystic Fibrosis</tradeName>
    <deviceName>MutaPLATE® Cystic Fibrosis</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <lastUpdated>2026-07-06T00:47:48.471Z</lastUpdated>
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    <tradeName>MutaPLATE® Cystic Fibrosis</tradeName>
    <deviceName>MutaPLATE® Cystic Fibrosis</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF190832</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:47.672Z</lastUpdated>
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