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    <tradeName>+ENTI301136200C</tradeName>
    <deviceName>Corynebacterium diphtheriae toxin IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:05:49.465Z</lastUpdated>
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    <basicUdiDi>B-+ENTI301134800G</basicUdiDi>
    <tradeName>+ENTI301134800G</tradeName>
    <deviceName>Brucella IgM</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>BRUCELLA</emdnDescription>
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    <udiDi>+ENTI301134790O</udiDi>
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    <tradeName>+ENTI301134790O</tradeName>
    <deviceName>Brucella IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>+ENTI301134760L</udiDi>
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    <deviceName>Bordetella pertussis toxin (PT) IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>30113476</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:05:35.812Z</lastUpdated>
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    <udiDi>+ENTI301134750K</udiDi>
    <basicUdiDi>B-+ENTI301134750K</basicUdiDi>
    <tradeName>+ENTI301134750K</tradeName>
    <deviceName>Bordetella pertussis toxin (PT) 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>
    <emdnCode>W0105011707</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30113475</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:05:35.009Z</lastUpdated>
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    <udiDi>+ENTI301134740J</udiDi>
    <basicUdiDi>B-+ENTI301134740J</basicUdiDi>
    <tradeName>+ENTI301134740J</tradeName>
    <deviceName>Bordetella pertussis IgM</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>BORDETELLA PERTUSSIS / PARAPERTUSSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30113474</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:05:34.218Z</lastUpdated>
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    <udiDi>+ENTI301134730I</udiDi>
    <basicUdiDi>B-+ENTI301134730I</basicUdiDi>
    <tradeName>+ENTI301134730I</tradeName>
    <deviceName>Bordetella pertussis IgG</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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    <deviceStatus>Piyasada</deviceStatus>
    <reference>30113473</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:05:30.320Z</lastUpdated>
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    <udiDi>+ENTI301134720H</udiDi>
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    <tradeName>+ENTI301134720H</tradeName>
    <deviceName>Bordetella pertussis IgA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30113472</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:05:28.731Z</lastUpdated>
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    <udiDi>TET01BK</udiDi>
    <basicUdiDi>B-TET01BK</basicUdiDi>
    <tradeName>TET01BK</tradeName>
    <deviceName>Tetanus Toxid IgG ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011709</emdnCode>
    <emdnDescription>TETANUS (CLOSTRIDIUM T.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-TET01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:00:49.926Z</lastUpdated>
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    <udiDi>D-ILEP-R402AD</udiDi>
    <basicUdiDi>B-ILEP-R402AD</basicUdiDi>
    <tradeName>Leptospira IgG/IgM Rapid Test Cassette</tradeName>
    <deviceName>Leptospira IgG/IgM 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>W0105011704</emdnCode>
    <emdnDescription>LEPTOSPIRA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILEP-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:12:15.020Z</lastUpdated>
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    <udiDi>ILE-DIP016B</udiDi>
    <basicUdiDi>B-ILE-DIP016B</basicUdiDi>
    <tradeName>ILE-DIP016B</tradeName>
    <deviceName>Diphtheria Toxid IgG ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Kassel GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILE-DIP01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:10:24.519Z</lastUpdated>
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    <udiDi>D-IBA-R40268</udiDi>
    <basicUdiDi>B-IBA-R40268</basicUdiDi>
    <tradeName>Brucella Abortus Antigen Rapid Test Cassette</tradeName>
    <deviceName>Brucella Abortus 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>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBA-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:04:23.324Z</lastUpdated>
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    <udiDi>D-GKPD127XJ</udiDi>
    <basicUdiDi>B-GKPD127XJ</basicUdiDi>
    <tradeName>Vibrio cholerae O1 and O139 Antigen Rapid Test Kit</tradeName>
    <deviceName>Vibrio cholerae O1 and O139 Antigen Rapid Test Kit</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD127</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:37:45.469Z</lastUpdated>
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    <udiDi>D-GCVCH(O1)-602aHGTJ</udiDi>
    <basicUdiDi>B-GCVCH(O1)-602aHGTJ</basicUdiDi>
    <tradeName>V. cholerae O1 Ag Rapid Test Cassette (Feces)</tradeName>
    <deviceName>V. cholerae O1 Ag Rapid Test Cassette (Feces)</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>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCVCH(O1)-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:33:07.939Z</lastUpdated>
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    <udiDi>D-GCVCH(O1)-602a7J</udiDi>
    <basicUdiDi>B-GCVCH(O1)-602a7J</basicUdiDi>
    <tradeName>V. cholerae O1 Ag Rapid Test Cassette (Feces)</tradeName>
    <deviceName>V. cholerae O1 Ag Rapid Test Cassette (Feces)</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>
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    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCVCH(O1)-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:33:06.340Z</lastUpdated>
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    <udiDi>D-GCVCH(O1/O9)-602aK7</udiDi>
    <basicUdiDi>B-GCVCH(O1/O9)-602aK7</basicUdiDi>
    <tradeName>V. cholerae O1/O139 Ag Combo Rapid Test Cassette (Feces)</tradeName>
    <deviceName>V. cholerae O1/O139 Ag Combo Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCVCH(O1/O9)-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <udiDi>D-GCVCH(O1/O9)-602aHG3D</udiDi>
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    <tradeName>V. cholerae O1/O139 Ag Rapid Test Cassette (Feces)</tradeName>
    <deviceName>V. cholerae O1/O139 Ag Rapid Test Cassette (Feces)</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>
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    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCVCH(O1/O9)-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:33:04.480Z</lastUpdated>
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    <udiDi>D-GCTB-402aZK</udiDi>
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    <tradeName>Tuberculosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Tuberculosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCTB-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:32:33.898Z</lastUpdated>
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    <tradeName>Tuberculosis IgG/IgM Rapid Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>Tuberculosis IgG/IgM Rapid Test Cassette (Serum/Plasma)</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>
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    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCTB-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:32:32.296Z</lastUpdated>
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    <tradeName>Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</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>W0105011704</emdnCode>
    <emdnDescription>LEPTOSPIRA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCLEP(IgG/IgM)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:56.354Z</lastUpdated>
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