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    <udiDi>05944759080126</udiDi>
    <basicUdiDi>5944759080VTCDABGDH25B6X8</basicUdiDi>
    <tradeName>Clostridium difficile GDH+Toxin A+Toxin B Combo, Rapid Test Cassette (Feces), positive controls included Test rapid determinare Clostridium difficile GDH+Toxina A+Toxina B, caseta COMBO (materii fecale) cu controale pozitive swab incluse</tradeName>
    <deviceName>Clostridium difficile GDH+Toxin A+Toxin B Combo, Rapid Test Cassette (Feces), positive controls included Test rapid determinare Clostridium difficile GDH+Toxina A+Toxina B, caseta COMBO (materii fecale) cu controale pozitive swab incluse</deviceName>
    <manufacturerName>VitroBioChem SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000010877</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011803</emdnCode>
    <emdnDescription>C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-CDABGDH-25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:25:44.476Z</lastUpdated>
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    <udiDi>D-ICD-R635BWB</udiDi>
    <basicUdiDi>B-ICD-R635BWB</basicUdiDi>
    <tradeName>Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette</tradeName>
    <deviceName>Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</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>ICD-R635B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:58.391Z</lastUpdated>
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    <udiDi>D-ICD-635B3B</udiDi>
    <basicUdiDi>B-ICD-635B3B</basicUdiDi>
    <tradeName>Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette</tradeName>
    <deviceName>Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</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>ICD-635B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:42:38.282Z</lastUpdated>
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    <udiDi>D-GCCD-602aRS</udiDi>
    <basicUdiDi>B-GCCD-602aRS</basicUdiDi>
    <tradeName>Clostridium difficile GDH &amp; Toxin A/B Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Clostridium difficile GDH &amp; Toxin A/B 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>
    <emdnCode>W0105011803</emdnCode>
    <emdnDescription>C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCD-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:17.151Z</lastUpdated>
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    <udiDi>D-2037MGY</udiDi>
    <basicUdiDi>B-2037MGY</basicUdiDi>
    <tradeName>mariPOC® CDI test plate</tradeName>
    <deviceName>mariPOC® CDI test plate</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</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>2037M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:28:11.442Z</lastUpdated>
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    <udiDi>16972698604222</udiDi>
    <basicUdiDi>B-16972698604222</basicUdiDi>
    <tradeName>C. difficile GDH &amp; Toxin A+B Combo Rapid Test</tradeName>
    <deviceName>C. difficile GDH &amp; Toxin A+B Combo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>P221115</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:53:05.320Z</lastUpdated>
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    <udiDi>16972698601399</udiDi>
    <basicUdiDi>B-16972698601399</basicUdiDi>
    <tradeName>C. difficile GDH &amp; Toxin A/B Combo Rapid Test</tradeName>
    <deviceName>C. difficile GDH &amp; Toxin A/B Combo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>P221109</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:20.328Z</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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  <row>
    <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>00857031002059</udiDi>
    <basicUdiDi>857031002CDIFFAGTOX001SJ</basicUdiDi>
    <tradeName>00857031002059</tradeName>
    <deviceName>C. DIFF QUIK CHEK COMPLETE</deviceName>
    <manufacturerName>TECHLAB, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008412</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011803</emdnCode>
    <emdnDescription>C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T30525C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:31:12.311Z</lastUpdated>
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    <udiDi>06952804803810</udiDi>
    <basicUdiDi>B-06952804803810</basicUdiDi>
    <tradeName>C. difficile Toxin B FIA</tradeName>
    <deviceName>C. difficile Toxin B FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</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>CDF B-F23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:25:56.967Z</lastUpdated>
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    <udiDi>06952804803797</udiDi>
    <basicUdiDi>B-06952804803797</basicUdiDi>
    <tradeName>C. difficile Toxin A FIA</tradeName>
    <deviceName>C. difficile Toxin A FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</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>CDF A-F23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:25:56.202Z</lastUpdated>
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