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    <basicUdiDi>B-+ENTI301136170I</basicUdiDi>
    <tradeName>+ENTI301136170I</tradeName>
    <deviceName>Candida albicans IgA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30113617</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:05:43.810Z</lastUpdated>
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    <udiDi>+ENTI301134710G</udiDi>
    <basicUdiDi>B-+ENTI301134710G</basicUdiDi>
    <tradeName>+ENTI301134710G</tradeName>
    <deviceName>Aspergillus fumigatus IgM</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30113471</reference>
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    <udiDi>+ENTI301134680M</udiDi>
    <basicUdiDi>B-+ENTI301134680M</basicUdiDi>
    <tradeName>+ENTI301134680M</tradeName>
    <deviceName>Aspergillus fumigatus IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>ASPERGILLUS</emdnDescription>
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    <tradeName>β-Glucan Test R2: LAL Reagent</tradeName>
    <deviceName>β-Glucan Test R1: Pretreatment Solution, β-Glucan Test R2: LAL Reagent, LAL Control</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060304</emdnCode>
    <emdnDescription>BETA-D-GLUCAN (PAN-FUNGAL MARKERS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>997-04101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:42:55.252Z</lastUpdated>
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    <udiDi>D-ICRG-R4028A</udiDi>
    <basicUdiDi>B-ICRG-R4028A</basicUdiDi>
    <tradeName>Cryptococcus Antigen Rapid Test Cassette</tradeName>
    <deviceName>Cryptococcus Antigen Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICRG-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:05:13.795Z</lastUpdated>
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    <udiDi>D-ICA-R5026W</udiDi>
    <basicUdiDi>B-ICA-R5026W</basicUdiDi>
    <tradeName>Candida albicans Rapid Test Cassette</tradeName>
    <deviceName>Candida albicans Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA-R502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:04:43.328Z</lastUpdated>
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    <udiDi>D-GKPD135XH</udiDi>
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    <tradeName>Candida albicans Ag Rapid Test Kit</tradeName>
    <deviceName>Candida albicans Ag Rapid Test Kit</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:09.597Z</lastUpdated>
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    <udiDi>D-GCCr(Ag)-402aRU</udiDi>
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    <tradeName>Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid)</tradeName>
    <deviceName>Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCr(Ag)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:31.988Z</lastUpdated>
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    <udiDi>D-GCCr(Ag)-402aHGDP</udiDi>
    <basicUdiDi>B-GCCr(Ag)-402aHGDP</basicUdiDi>
    <tradeName>Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid)</tradeName>
    <deviceName>Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCr(Ag)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:30.328Z</lastUpdated>
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    <udiDi>D-GCCA-502aHGAL</udiDi>
    <basicUdiDi>B-GCCA-502aHGAL</basicUdiDi>
    <tradeName>Candida albicans Antigen Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Candida albicans Antigen Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCA-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:06.744Z</lastUpdated>
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    <udiDi>D-GCCA-502aQC</udiDi>
    <basicUdiDi>B-GCCA-502aQC</basicUdiDi>
    <tradeName>Candida albicans Antigen Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Candida albicans Antigen Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCA-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:04.437Z</lastUpdated>
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    <udiDi>D-37700277935712T</udiDi>
    <basicUdiDi>B-37700277935712T</basicUdiDi>
    <tradeName>ASPERGILLUS WB IgG</tradeName>
    <deviceName>ASPERGILLUS WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASP-WB96G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:27.472Z</lastUpdated>
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    <udiDi>D-37700277935642W</udiDi>
    <basicUdiDi>B-37700277935642W</basicUdiDi>
    <tradeName>ASPERGILLUS WB IgG</tradeName>
    <deviceName>ASPERGILLUS WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASP-WB24G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:26.665Z</lastUpdated>
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    <udiDi>D-37700277935572Z</udiDi>
    <basicUdiDi>B-37700277935572Z</basicUdiDi>
    <tradeName>ASPERGILLUS WB IgG</tradeName>
    <deviceName>ASPERGILLUS WB IgG</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASP-WB12G</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:25.070Z</lastUpdated>
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    <udiDi>D-37700277933732M</udiDi>
    <basicUdiDi>B-37700277933732M</basicUdiDi>
    <tradeName>ASPERGILLUS ICT IgG-IgM</tradeName>
    <deviceName>ASPERGILLUS ICT IgG-IgM</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASPG Ab ICT100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:56:40.978Z</lastUpdated>
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    <tradeName>ASPERGILLUS ICT IgG-IgM</tradeName>
    <deviceName>ASPERGILLUS ICT IgG-IgM</deviceName>
    <manufacturerName>LDBIO DIAGNOSTICS</manufacturerName>
    <manufacturerSrn>FR-MF-000021697</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASPG Ab ICT20</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
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    <tradeName>MONO -VIDITEST anti-Aspergillus fumigatus IgA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-702-12</reference>
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    <tradeName>MONO-VIDITEST anti-Aspergillus fumigatus IgM</tradeName>
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    <tradeName>MONO-VIDITEST anti-Aspergillus fumigatus IgG</tradeName>
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    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>B-28594036045143</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-Aspergillus fumigatus IgA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105060301</emdnCode>
    <emdnDescription>ASPERGILLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-514</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:22:17.662Z</lastUpdated>
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