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    <deviceName>VIDAS® C. difficile Toxin A &amp; B</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
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    <tradeName>Clostridium difficile Toxin A+B</tradeName>
    <deviceName>Clostridium difficile Toxin A+B</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
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    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <basicUdiDi>B-86060313276530</basicUdiDi>
    <tradeName>Clostridium difficile Toxin A+B</tradeName>
    <deviceName>Clostridium difficile Toxin A+B</deviceName>
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    <lastUpdated>2026-07-29T23:29:45.672Z</lastUpdated>
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    <udiDi>06974849369762</udiDi>
    <basicUdiDi>697484936HWTS-EV032AYS</basicUdiDi>
    <tradeName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</tradeName>
    <deviceName>Nucleic Acid Detection Kit for Clostridium Difficile toxin A/B gene (Fluorescence PCR)</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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W0105011802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:48:59.560Z</lastUpdated>
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    <udiDi>06974849369779</udiDi>
    <basicUdiDi>697484936HWTS-EV032AYS</basicUdiDi>
    <tradeName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</tradeName>
    <deviceName></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>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011802</emdnCode>
    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-EVO32HL</reference>
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    <lastUpdated>2026-07-23T03:46:03.426Z</lastUpdated>
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    <udiDi>06974849369786</udiDi>
    <basicUdiDi>697484936HWTS-EV032AYS</basicUdiDi>
    <tradeName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</tradeName>
    <deviceName></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>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-23T03:46:02.351Z</lastUpdated>
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    <udiDi>04099466104038</udiDi>
    <basicUdiDi>B-04099466104038</basicUdiDi>
    <tradeName>04099466104038</tradeName>
    <deviceName>Serazym® Clostridium difficile Toxin A+B</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:27.396Z</lastUpdated>
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    <udiDi>D-GCCD(ToxinAB)-602aZC</udiDi>
    <basicUdiDi>B-GCCD(ToxinAB)-602aZC</basicUdiDi>
    <tradeName>Clostridium difficile Toxin A&amp;B Rapid Test Casette (Feces)</tradeName>
    <deviceName>Clostridium difficile Toxin A&amp;B Rapid Test Casette (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>
    <emdnCode>W0105011802</emdnCode>
    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCD(Toxin A/B)-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:12.349Z</lastUpdated>
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    <udiDi>D-2R04ES</udiDi>
    <basicUdiDi>B-2R04ES</basicUdiDi>
    <tradeName>mariPOC® Clostridium difficile Toxin A/B test reagent</tradeName>
    <deviceName>mariPOC® Clostridium difficile Toxin A/B test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011802</emdnCode>
    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2R04</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:58:35.613Z</lastUpdated>
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    <udiDi>08684387211895</udiDi>
    <basicUdiDi>B-08684387211895</basicUdiDi>
    <tradeName>RevoDx Clostridium difficile qPCR Kit</tradeName>
    <deviceName>RevoDx Clostridium difficile qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011802</emdnCode>
    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202409-500</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:51:52.188Z</lastUpdated>
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    <udiDi>08684387211888</udiDi>
    <basicUdiDi>B-08684387211888</basicUdiDi>
    <tradeName>RevoDx Clostridium difficile qPCR Kit</tradeName>
    <deviceName>RevoDx Clostridium difficile qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011802</emdnCode>
    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202409-100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:51:51.369Z</lastUpdated>
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    <udiDi>08684387211871</udiDi>
    <basicUdiDi>B-08684387211871</basicUdiDi>
    <tradeName>RevoDx Clostridium difficile qPCR Kit</tradeName>
    <deviceName>RevoDx Clostridium difficile qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011802</emdnCode>
    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202409-50</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:51:50.576Z</lastUpdated>
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    <udiDi>08683548258779</udiDi>
    <basicUdiDi>B-08683548258779</basicUdiDi>
    <tradeName>LyoSens Clostridium difficile toxins A+B Detection qPCR Kit</tradeName>
    <deviceName>Clostridium difficile toxins A+B Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011802</emdnCode>
    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO23</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:19:55.557Z</lastUpdated>
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    <udiDi>08683548258649</udiDi>
    <basicUdiDi>B-08683548258649</basicUdiDi>
    <tradeName>LyoSens Clostridium diﬀicile toxin B Detection qPCR Kit</tradeName>
    <deviceName>Clostridium diﬀicile toxin B Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:19:36.354Z</lastUpdated>
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    <tradeName>LyoSens Clostridium diﬀicile toxin A Detection qPCR Kit</tradeName>
    <deviceName>Clostridium diﬀicile toxin A Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO09</reference>
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    <lastUpdated>2026-07-08T21:19:35.552Z</lastUpdated>
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    <basicUdiDi>B-08683548257390</basicUdiDi>
    <tradeName>ChainFor Clostridium diﬀicile Binary Toxin A/B Detection qPCR Kit</tradeName>
    <deviceName>Clostridium diﬀicile Binary Toxin A/B Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP37</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:15:48.658Z</lastUpdated>
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    <basicUdiDi>B-08683548257383</basicUdiDi>
    <tradeName>ChainFor Clostridium diﬀicile Toxin B Detection qPCR Kit</tradeName>
    <deviceName>Clostridium diﬀicile Toxin B Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:15:47.854Z</lastUpdated>
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    <basicUdiDi>B-08683548257376</basicUdiDi>
    <tradeName>ChainFor Clostridium diﬀicile Toxin A Detection qPCR Kit</tradeName>
    <deviceName>Clostridium diﬀicile Toxin A Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-08T21:15:47.054Z</lastUpdated>
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    <basicUdiDi>B-08683548254214</basicUdiDi>
    <tradeName>RapidFor™ C.difficile Toxin A + B Combo Rapid Test Kit</tradeName>
    <deviceName>C.difficile Toxin A + B Combo Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD89</reference>
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    <lastUpdated>2026-07-08T21:14:23.881Z</lastUpdated>
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    <tradeName>Clostridium dificile GDH, Toxin A and Toxin B Combo Rapid Test</tradeName>
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    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCDT067G</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:59:28.598Z</lastUpdated>
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