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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>
    <legislation>IVDD</legislation>
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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>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>FMPCR-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:08:06.113Z</lastUpdated>
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    <udiDi>06970514081137</udiDi>
    <basicUdiDi>B-06970514081137</basicUdiDi>
    <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>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>CRYPTOCOCCUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCPCR-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:08:03.699Z</lastUpdated>
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    <basicUdiDi>B-06970514081120</basicUdiDi>
    <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>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105060403</emdnCode>
    <emdnDescription>CRYPTOCOCCUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCPCR-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:58.899Z</lastUpdated>
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    <tradeName>Talaromyces marneffei Molecular Detection Kit (Real-time PCR)</tradeName>
    <deviceName>Talaromyces marneffei Molecular Detection Kit (Real-time PCR)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>MYCOLOGY NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTMPCR-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:56.496Z</lastUpdated>
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    <tradeName>Talaromyces marneffei Molecular Detection Kit (Real-time PCR)</tradeName>
    <deviceName>Talaromyces marneffei 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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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>MYCOLOGY NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTMPCR-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:55.291Z</lastUpdated>
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    <basicUdiDi>B-06970514081076</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060402</emdnCode>
    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCUPCR-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:52.884Z</lastUpdated>
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    <udiDi>06970514081069</udiDi>
    <basicUdiDi>B-06970514081069</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060402</emdnCode>
    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCUPCR-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:48.097Z</lastUpdated>
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    <deviceName>Candida Molecular Detection Kit (Real-time PCR)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060402</emdnCode>
    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCAPCR-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:45.678Z</lastUpdated>
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    <deviceName>Candida Molecular Detection Kit (Real-time PCR)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060402</emdnCode>
    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCAPCR-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:44.505Z</lastUpdated>
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    <basicUdiDi>B-06970514081038</basicUdiDi>
    <tradeName>06970514081038</tradeName>
    <deviceName>Pneumocystis Molecular Detection Kit (Real-time PCR)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060405</emdnCode>
    <emdnDescription>PNEUMOCYSTIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FPPCR-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:40.875Z</lastUpdated>
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    <basicUdiDi>B-06970514081021</basicUdiDi>
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    <deviceName>Pneumocystis 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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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105060405</emdnCode>
    <emdnDescription>PNEUMOCYSTIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FPPCR-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:37.278Z</lastUpdated>
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    <deviceName>Aspergillus Molecular Detection Kit (Real-time PCR)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105060401</emdnCode>
    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAPCR-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:34.874Z</lastUpdated>
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    <deviceName>Aspergillus 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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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>ASPERGILLUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAPCR-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:33.722Z</lastUpdated>
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    <tradeName>Aspergillus, Cryptococcus, Candida Albicans Molecular Detection Kit (Real-time PCR)</tradeName>
    <deviceName>Aspergillus, Cryptococcus, Candida Albicans Molecular Detection Kit (Real-time PCR)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105060499</emdnCode>
    <emdnDescription>MYCOLOGY NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FPCR-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:31.277Z</lastUpdated>
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    <tradeName>06970514080673</tradeName>
    <deviceName>Cryptococcal Capsular Polysaccharide Detection Kit (CLIA)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXMCLIA-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:12.057Z</lastUpdated>
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    <tradeName>Candida Mannan IgM Antibody Detection K-Set(CLIA)</tradeName>
    <deviceName>Candida IgM Antibody Detection Kit(CLIA)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMCLIA-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:08.465Z</lastUpdated>
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    <tradeName>06970514080659</tradeName>
    <deviceName>Candida IgG Antibody Detection Kit (CLIA)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGCLIA-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:07:06.051Z</lastUpdated>
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