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    <tradeName>LyoSens Clostridium diﬀicile Detection qPCR Kit</tradeName>
    <deviceName>Clostridium diﬀicile Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:20:52.509Z</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>
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    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
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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>
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    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
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    <udiDi>08683548258632</udiDi>
    <basicUdiDi>B-08683548258632</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:19:35.552Z</lastUpdated>
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    <udiDi>08683548258625</udiDi>
    <basicUdiDi>B-08683548258625</basicUdiDi>
    <tradeName>LyoSens Clostridium diﬀicile Detection qPCR Kit</tradeName>
    <deviceName>Clostridium diﬀicile 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>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO08</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:19:34.756Z</lastUpdated>
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    <udiDi>08683548257390</udiDi>
    <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>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011802</emdnCode>
    <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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    <udiDi>08683548257383</udiDi>
    <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>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011802</emdnCode>
    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP36</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:15:47.854Z</lastUpdated>
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    <udiDi>08683548257376</udiDi>
    <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>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011802</emdnCode>
    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP35</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:15:47.054Z</lastUpdated>
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    <udiDi>08683548257369</udiDi>
    <basicUdiDi>B-08683548257369</basicUdiDi>
    <tradeName>ChainFor Clostridium diﬀicile Detection qPCR Kit</tradeName>
    <deviceName>Clostridium diﬀicile 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>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP34</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:15:46.254Z</lastUpdated>
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    <udiDi>08683548254993</udiDi>
    <basicUdiDi>B-08683548254993</basicUdiDi>
    <tradeName>RapidFor™ C.difficile GDH + Toxin A + Toxin B Combo Rapid Test Kit</tradeName>
    <deviceName>C.difficile GDH + Toxin A + Toxin B Combo Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011803</emdnCode>
    <emdnDescription>C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:14:31.892Z</lastUpdated>
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    <udiDi>08683548254214</udiDi>
    <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>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011802</emdnCode>
    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD89</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:14:23.881Z</lastUpdated>
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    <udiDi>08683548254191</udiDi>
    <basicUdiDi>B-08683548254191</basicUdiDi>
    <tradeName>The RapidFor™ C.difficile GDH Rapid Test Kit</tradeName>
    <deviceName>C.difficile GDH Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011801</emdnCode>
    <emdnDescription>C.DIFFICILE GDH DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD88</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:14:23.230Z</lastUpdated>
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    <udiDi>06976202762234</udiDi>
    <basicUdiDi>B-06976202762234</basicUdiDi>
    <tradeName>C. difficile Toxin A/B+GDH Rapid Test</tradeName>
    <deviceName>C. difficile Toxin A/B+GDH Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011803</emdnCode>
    <emdnDescription>C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GICD-632</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:36:39.138Z</lastUpdated>
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    <udiDi>06976202762210</udiDi>
    <basicUdiDi>B-06976202762210</basicUdiDi>
    <tradeName>C. difficile GDH Ag Rapid Test</tradeName>
    <deviceName>C. difficile GDH Ag Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>C.DIFFICILE GDH DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GICDG-602</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:36:34.339Z</lastUpdated>
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    <udiDi>06975447582256</udiDi>
    <basicUdiDi>B-06975447582256</basicUdiDi>
    <tradeName>06975447582256</tradeName>
    <deviceName>Toxigenic Clostridium difficile Gene (toxinA, toxinB) Detection Kit (PCR Fluorescence )</deviceName>
    <manufacturerName>Igenesis(Shanghai)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001552</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>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106-0159-01</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:50:29.752Z</lastUpdated>
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    <tradeName>06974795550474</tradeName>
    <deviceName>Clostridium Difficile Toxin Gene Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10210110B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:44:20.163Z</lastUpdated>
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    <udiDi>06974795550467</udiDi>
    <basicUdiDi>B-06974795550467</basicUdiDi>
    <tradeName>06974795550467</tradeName>
    <deviceName>Clostridium Difficile Toxin Gene Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10210110A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:44:19.355Z</lastUpdated>
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    <udiDi>06974323011286</udiDi>
    <basicUdiDi>B-06974323011286</basicUdiDi>
    <tradeName>06974323011286</tradeName>
    <deviceName>Real-time PCR Diagnostic Kit for Rapid Detection of Clostridium difficile</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A2340</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:46:49.327Z</lastUpdated>
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    <tradeName>06974323011279</tradeName>
    <deviceName>Real-time PCR Diagnostic Kit for Rapid Detection of Clostridium difficile</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011804</emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:46:48.542Z</lastUpdated>
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    <udiDi>06974238911121</udiDi>
    <basicUdiDi>B-06974238911121</basicUdiDi>
    <tradeName>Clostridium difficile Antigen Rapid Tes</tradeName>
    <deviceName>Clostridium difficile Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011801</emdnCode>
    <emdnDescription>C.DIFFICILE GDH DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCDI058G</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:59:56.967Z</lastUpdated>
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