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    <tradeName>Allplex™ H.pylori &amp; ClariR Assay</tradeName>
    <deviceName>Allplex™ H.pylori &amp; ClariR Assay</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <reference>HC10199Y</reference>
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    <lastUpdated>2026-07-10T09:44:37.643Z</lastUpdated>
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    <udiDi>08800076700451</udiDi>
    <basicUdiDi>B-08800076700451</basicUdiDi>
    <tradeName>HelicoSign Dry</tradeName>
    <deviceName>Helicosign Dry</deviceName>
    <manufacturerName>GenBody Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000043626</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <lastUpdated>2026-07-10T04:22:41.093Z</lastUpdated>
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    <udiDi>08697962616268</udiDi>
    <basicUdiDi>B-08697962616268</basicUdiDi>
    <tradeName>SOFTEC H.Pylori Antigen test</tradeName>
    <deviceName>SOFTEC H.Pylori Antigen test</deviceName>
    <manufacturerName>ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000046897</manufacturerSrn>
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    <udiDi>08685115807632</udiDi>
    <basicUdiDi>B-08685115807632</basicUdiDi>
    <tradeName>LyoSens  H. pylori qPCR Kit</tradeName>
    <deviceName>H. pylori qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105010403</emdnCode>
    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO137</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:23:08.597Z</lastUpdated>
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    <udiDi>08685115807519</udiDi>
    <basicUdiDi>B-08685115807519</basicUdiDi>
    <tradeName>LyoSens  H.pylori/Clarithromycin Genotyping qPCR Kit</tradeName>
    <deviceName>H.pylori/Clarithromycin Genotyping 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>W0105010403</emdnCode>
    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO144</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:23:04.594Z</lastUpdated>
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    <udiDi>08684387210874</udiDi>
    <basicUdiDi>B-08684387210874</basicUdiDi>
    <tradeName>RevoDx Helicobacter pylori qPCR Kit</tradeName>
    <deviceName>RevoDx Helicobacter pylori 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>W0105010403</emdnCode>
    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202405-25</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:47:58.194Z</lastUpdated>
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    <udiDi>08684387210355</udiDi>
    <basicUdiDi>B-08684387210355</basicUdiDi>
    <tradeName>RevoDx Helicobacter pylori qPCR Kit</tradeName>
    <deviceName>RevoDx Helicobacter pylori qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010403</emdnCode>
    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202405-100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:46:58.791Z</lastUpdated>
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    <udiDi>08683347941421</udiDi>
    <basicUdiDi>B-08683347941421</basicUdiDi>
    <tradeName>RapidFor™H.Pylori Ab Rapid Test Kit</tradeName>
    <deviceName>H.Pylori Ab 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>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD35</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:04:33.604Z</lastUpdated>
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    <udiDi>00810114460993</udiDi>
    <basicUdiDi>081011446R0192CEF</basicUdiDi>
    <tradeName>OnSite® H. pylori Ag Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CTK Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024900</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0192C-30T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:51:30.751Z</lastUpdated>
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    <udiDi>00810114461006</udiDi>
    <basicUdiDi>081011446R0192CEF</basicUdiDi>
    <tradeName>Aria® H. pylori Ag Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CTK Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024900</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0192C-25T-AR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:51:30.735Z</lastUpdated>
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    <udiDi>00810114461013</udiDi>
    <basicUdiDi>081011446R0192CEF</basicUdiDi>
    <tradeName>Aria® H. pylori Ag Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CTK Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024900</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0192C-30T-AR</reference>
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    <lastUpdated>2026-07-08T06:51:30.713Z</lastUpdated>
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    <udiDi>00810114461020</udiDi>
    <basicUdiDi>081011446R0192CEF</basicUdiDi>
    <tradeName>Aria® H. pylori Ag Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CTK Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024900</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0192C-50T-AR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:51:30.688Z</lastUpdated>
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    <udiDi>00810114461808</udiDi>
    <basicUdiDi>081011446R0192CEF</basicUdiDi>
    <tradeName>OnSite® H. pylori Ag Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CTK Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024900</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0192C-10T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:51:30.388Z</lastUpdated>
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    <basicUdiDi>081011446R0192CEF</basicUdiDi>
    <tradeName>OnSite® H. pylori Ag Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CTK Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024900</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0192C-20T</reference>
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    <lastUpdated>2026-07-08T06:51:30.376Z</lastUpdated>
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    <udiDi>00810114461822</udiDi>
    <basicUdiDi>081011446R0192CEF</basicUdiDi>
    <tradeName>Aria® H. pylori Ag Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CTK Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024900</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <reference>R0192C-10T-AR</reference>
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    <basicUdiDi>081011446R0192CEF</basicUdiDi>
    <tradeName>Aria® H. pylori Ag Rapid Test</tradeName>
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    <manufacturerName>CTK Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024900</manufacturerSrn>
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    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0192C-20T-AR</reference>
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    <lastUpdated>2026-07-08T06:51:30.338Z</lastUpdated>
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    <udiDi>06979878282020</udiDi>
    <basicUdiDi>B-06979878282020</basicUdiDi>
    <tradeName>06979878282020</tradeName>
    <deviceName>Helicobacter pylori Antigen Test (Colloidal Gold)</deviceName>
    <manufacturerName>Huzhou Jierunxin Biotechnology Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000047637</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001058</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:51:58.580Z</lastUpdated>
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    <tradeName>06979502240747</tradeName>
    <deviceName>Helicobacter Pylori (HP) Typing test cassette (Lateral Flow Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>H. PYLORI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG9101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:47:58.889Z</lastUpdated>
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    <tradeName>06978896416165</tradeName>
    <deviceName>Helicobacter pylori Antigen (Hp-Ag)Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>06978896416158</tradeName>
    <deviceName>Helicobacter pylori Antigen (Hp-Ag)Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
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    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T22:50:19.918Z</lastUpdated>
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