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    <deviceName>ST AIA-PACK D-Dimer</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
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    <udiDi>10850076346284</udiDi>
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    <tradeName>D-Dimer Test Kit (CLIA)</tradeName>
    <deviceName>D-Dimer Test Kit (CLIA)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <udiDi>08809317540641</udiDi>
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    <tradeName>FREND D-Dimer</tradeName>
    <deviceName>FRDD 025</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <lastUpdated>2026-07-10T10:42:38.573Z</lastUpdated>
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    <udiDi>08683555624307</udiDi>
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    <tradeName>D-DIMER Kit</tradeName>
    <deviceName>D-DIMER Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B33447</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:54:49.715Z</lastUpdated>
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    <udiDi>08683555622761</udiDi>
    <basicUdiDi>B-08683555622761</basicUdiDi>
    <tradeName>D-DIMER Kit</tradeName>
    <deviceName>D-DIMER Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B27448</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:54:01.625Z</lastUpdated>
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    <udiDi>08683555619617</udiDi>
    <basicUdiDi>B-08683555619617</basicUdiDi>
    <tradeName>D-DIMER Kit</tradeName>
    <deviceName>D-DIMER Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B35447</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:51:58.942Z</lastUpdated>
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    <udiDi>08683555613875</udiDi>
    <basicUdiDi>B-08683555613875</basicUdiDi>
    <tradeName>D-Dimer Kit</tradeName>
    <deviceName>D-Dimer Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B24445</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:34:58.202Z</lastUpdated>
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    <udiDi>08683555611154</udiDi>
    <basicUdiDi>B-08683555611154</basicUdiDi>
    <tradeName>D Dimer</tradeName>
    <deviceName>D Dimer</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B21447</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:27:46.418Z</lastUpdated>
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    <udiDi>08435287112054</udiDi>
    <basicUdiDi>B-08435287112054</basicUdiDi>
    <tradeName>08435287112054</tradeName>
    <deviceName>D-DIMER</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13519</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:46:31.049Z</lastUpdated>
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    <udiDi>08435287108972</udiDi>
    <basicUdiDi>B-08435287108972</basicUdiDi>
    <tradeName>08435287108972</tradeName>
    <deviceName>D-DIMER</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21519</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:42:58.734Z</lastUpdated>
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    <udiDi>08053172971922</udiDi>
    <basicUdiDi>B-08053172971922</basicUdiDi>
    <tradeName>D-Dimero</tradeName>
    <deviceName>D-Dimero/D-Dimer</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6737</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:47:37.437Z</lastUpdated>
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    <udiDi>06979878281382</udiDi>
    <basicUdiDi>B-06979878281382</basicUdiDi>
    <tradeName>06979878281382</tradeName>
    <deviceName>D-Dimer Test (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Huzhou Jierunxin Biotechnology Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000047637</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001032</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:51:17.619Z</lastUpdated>
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    <udiDi>06979469760395</udiDi>
    <basicUdiDi>B-06979469760395</basicUdiDi>
    <tradeName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D2403CC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:40:24.512Z</lastUpdated>
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    <udiDi>06979469760388</udiDi>
    <basicUdiDi>B-06979469760388</basicUdiDi>
    <tradeName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D2404CC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:40:20.511Z</lastUpdated>
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    <basicUdiDi>B-06979469760371</basicUdiDi>
    <tradeName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>D2402CC</reference>
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    <lastUpdated>2026-07-06T23:40:19.710Z</lastUpdated>
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    <basicUdiDi>B-06979469760364</basicUdiDi>
    <tradeName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
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    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D2402CL</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:40:18.912Z</lastUpdated>
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    <basicUdiDi>B-06979355921060</basicUdiDi>
    <tradeName>06979355921060</tradeName>
    <deviceName>D-Dimer Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:15.286Z</lastUpdated>
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    <deviceName>D-Dimer Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:14.487Z</lastUpdated>
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    <tradeName>06979355921046</tradeName>
    <deviceName>D-Dimer Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:13.691Z</lastUpdated>
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    <tradeName>06979355921039</tradeName>
    <deviceName>D-Dimer Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:02:09.682Z</lastUpdated>
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