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    <basicUdiDi>84354402_MDXRESIST_CAUL3</basicUdiDi>
    <tradeName>VIASURE Candida auris Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060404</emdnCode>
    <emdnDescription>CANDIDA AURIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CAU196TE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:54:07.928Z</lastUpdated>
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    <udiDi>06975344570127</udiDi>
    <basicUdiDi>B-06975344570127</basicUdiDi>
    <tradeName>Cryptococcal Antigen Rapid Test Strip</tradeName>
    <deviceName>Cryptococcal Antigen Rapid Test Strip</deviceName>
    <manufacturerName>Tianjin Jianbo Biological Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040307</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>C6002</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:28:51.339Z</lastUpdated>
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    <udiDi>06975344570103</udiDi>
    <basicUdiDi>B-06975344570103</basicUdiDi>
    <tradeName>Cryptococcal Antigen Rapid Test Cassette</tradeName>
    <deviceName>Cryptococcal Antigen Rapid Test Cassette</deviceName>
    <manufacturerName>Tianjin Jianbo Biological Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040307</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>C6004</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:28:49.745Z</lastUpdated>
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    <udiDi>06975070768317</udiDi>
    <basicUdiDi>B-06975070768317</basicUdiDi>
    <tradeName>Sharay (1-3)-β-D-Glucan (CLIA)</tradeName>
    <deviceName>Sharay (1-3)-β-D-Glucan (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060304</emdnCode>
    <emdnDescription>BETA-D-GLUCAN (PAN-FUNGAL MARKERS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000718</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:48:01.999Z</lastUpdated>
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    <udiDi>06975070768300</udiDi>
    <basicUdiDi>B-06975070768300</basicUdiDi>
    <tradeName>Sharay Lipopolysaccharide (CLIA)</tradeName>
    <deviceName>Sharay Lipopolysaccharide (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060399</emdnCode>
    <emdnDescription>MYCOLOGY IMMUNOASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000717</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:48:00.401Z</lastUpdated>
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    <udiDi>06975070767648</udiDi>
    <basicUdiDi>B-06975070767648</basicUdiDi>
    <tradeName>Sharay (1-3)-β-D-Glucan (CLIA)</tradeName>
    <deviceName>Sharay (1-3)-β-D-Glucan (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060304</emdnCode>
    <emdnDescription>BETA-D-GLUCAN (PAN-FUNGAL MARKERS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000653</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:44:16.070Z</lastUpdated>
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    <udiDi>06975070767631</udiDi>
    <basicUdiDi>B-06975070767631</basicUdiDi>
    <tradeName>Sharay Lipopolysaccharide (CLIA)</tradeName>
    <deviceName>Sharay Lipopolysaccharide (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060399</emdnCode>
    <emdnDescription>MYCOLOGY IMMUNOASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000652</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:44:15.249Z</lastUpdated>
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    <udiDi>06974854621176</udiDi>
    <basicUdiDi>B-06974854621176</basicUdiDi>
    <tradeName>Fungal 1,3-BETA-D Glucan Test</tradeName>
    <deviceName>Fungal 1,3-BETA-D Glucan Test</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060399</emdnCode>
    <emdnDescription>MYCOLOGY IMMUNOASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2206725</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:56:20.999Z</lastUpdated>
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    <udiDi>06974854620865</udiDi>
    <basicUdiDi>B-06974854620865</basicUdiDi>
    <tradeName>Candida Albican (Ca) Ag Rapid Test</tradeName>
    <deviceName>Candida Albican (Ca) Ag Rapid Test</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</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>P2211125</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:53:34.669Z</lastUpdated>
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  <row>
    <udiDi>06974849366204</udiDi>
    <basicUdiDi>B-06974849366204</basicUdiDi>
    <tradeName>Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Candida Albicans</tradeName>
    <deviceName>Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Candida Albicans</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-FG005A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:51:12.848Z</lastUpdated>
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    <udiDi>06974473307840</udiDi>
    <basicUdiDi>B-06974473307840</basicUdiDi>
    <tradeName>Cryptococcal Antigen Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>Cryptococcal Antigen Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060399</emdnCode>
    <emdnDescription>MYCOLOGY IMMUNOASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR019</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:11:59.974Z</lastUpdated>
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    <udiDi>06974473303064</udiDi>
    <basicUdiDi>B-06974473303064</basicUdiDi>
    <tradeName>Candida Albicans Antigen Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>Candida Albicans Antigen Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR025</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:10:31.820Z</lastUpdated>
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  <row>
    <udiDi>06973181850358</udiDi>
    <basicUdiDi>B-06973181850358</basicUdiDi>
    <tradeName>StrongStep® Candida albicans antigen Rapid Test</tradeName>
    <deviceName>Candida Albicans Antigen Rapid Test</deviceName>
    <manufacturerName>Nanjing Liming Bio-products Co. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041298</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>500030</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:52:14.913Z</lastUpdated>
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    <udiDi>06973181850334</udiDi>
    <basicUdiDi>B-06973181850334</basicUdiDi>
    <tradeName>StrongStep® Cryptococcal Antigen Rapid Test</tradeName>
    <deviceName>Cryptococcal Antigen Rapid Test</deviceName>
    <manufacturerName>Nanjing Liming Bio-products Co. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041298</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>502080</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:52:13.312Z</lastUpdated>
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    <udiDi>06971042229169</udiDi>
    <basicUdiDi>B-06971042229169</basicUdiDi>
    <tradeName>Pneumocystis jirovecii Real Time PCR Kit</tradeName>
    <deviceName>Pneumocystis jirovecii Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060499</emdnCode>
    <emdnDescription>MYCOLOGY NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QD-0082-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:03:37.436Z</lastUpdated>
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    <udiDi>06971042228995</udiDi>
    <basicUdiDi>B-06971042228995</basicUdiDi>
    <tradeName>Fungus Real Time PCR Kit</tradeName>
    <deviceName>Fungus Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060499</emdnCode>
    <emdnDescription>MYCOLOGY NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FD-0330-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:03:08.060Z</lastUpdated>
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    <udiDi>06971042228988</udiDi>
    <basicUdiDi>B-06971042228988</basicUdiDi>
    <tradeName>Candida Albicans Real Time PCR Kit</tradeName>
    <deviceName>Candida Albicans Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060402</emdnCode>
    <emdnDescription>CANDIDA ALBICANS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FD-0329-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:03:06.480Z</lastUpdated>
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    <udiDi>06971042225161</udiDi>
    <basicUdiDi>B-06971042225161</basicUdiDi>
    <tradeName>Cryptococcus Neoformans Real Time PCR Kit</tradeName>
    <deviceName>Cryptococcus Neoformans Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060499</emdnCode>
    <emdnDescription>MYCOLOGY NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FD-0328-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:56:59.057Z</lastUpdated>
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    <udiDi>04050598015234</udiDi>
    <basicUdiDi>B-04050598015234</basicUdiDi>
    <tradeName>PreventID® Dermatophyte</tradeName>
    <deviceName>PreventID® Dermatophyte</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060399</emdnCode>
    <emdnDescription>MYCOLOGY IMMUNOASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KSTDE001GP5.03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:50:51.953Z</lastUpdated>
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    <udiDi>04050598015227</udiDi>
    <basicUdiDi>B-04050598015227</basicUdiDi>
    <tradeName>PreventID® Dermatophyte</tradeName>
    <deviceName>PreventID® Dermatophyte</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060399</emdnCode>
    <emdnDescription>MYCOLOGY IMMUNOASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KSTDE001GP5.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:50:51.145Z</lastUpdated>
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