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    <tradeName>PreventID® Dermatophyte</tradeName>
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    <tradeName>PreventID® Dermatophyte</tradeName>
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    <tradeName>PreventID® Dermatophyte</tradeName>
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    <manufacturerName>Immundiagnostik AG</manufacturerName>
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    <tradeName>DermaGenius® 2.0 Complete Multiplex real-time PCR kit</tradeName>
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    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
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    <tradeName>PNEUMOCYSTIS JIROVECII REALTIME PCR KIT</tradeName>
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    <manufacturerName>Vircell, S.L</manufacturerName>
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    <deviceName>Long Life MycoGENIE® Pneumocystis jirovecii Real Time PCR</deviceName>
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    <deviceName>MycoGENIE® Pneumocystis jirovecii Real Time PCR</deviceName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>BIOSYNEX CryptoPS</tradeName>
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    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1120001-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:27:07.529Z</lastUpdated>
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    <tradeName>β-Glucan Test R1: Pretreatment Solution</tradeName>
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    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060304</emdnCode>
    <emdnDescription>MYCOLOGY CONTROLS - INF.IMM.</emdnDescription>
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    <reference>993-04201</reference>
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    <lastUpdated>2026-07-01T07:36:24.897Z</lastUpdated>
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    <deviceName>Candida auris and Antibiotic-Resistant Strain Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>B70201T2048</reference>
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    <lastUpdated>2026-06-30T06:55:38.917Z</lastUpdated>
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    <deviceName>Candida Auris Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <deviceName>Mucorales Molecular Detection Kit (Real-time PCR)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
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    <deviceName>Mucorales Molecular Detection Kit (Real-time PCR)</deviceName>
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    <tradeName>Cryptococcus Molecular Detection Kit (Real-time PCR)</tradeName>
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    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
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    <tradeName>Cryptococcus Molecular Detection Kit (Real-time PCR)</tradeName>
    <deviceName>Cryptococcus Molecular Detection Kit (Real-time PCR)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
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    <tradeName>Talaromyces marneffei Molecular Detection Kit (Real-time PCR)</tradeName>
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    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
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    <tradeName>Talaromyces marneffei Molecular Detection Kit (Real-time PCR)</tradeName>
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    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
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    <tradeName>Candida auris Molecular Detection Kit (Real-time PCR)</tradeName>
    <deviceName>Candida auris Molecular Detection Kit (Real-time PCR)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCUPCR-50</reference>
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    <lastUpdated>2026-06-30T01:07:52.884Z</lastUpdated>
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