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    <deviceName>RIDASCREEN® Helicobacter</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <tradeName>CHORUS HELICOBACTER PYLORI IgA</tradeName>
    <deviceName>CHORUS HELICOBACTER PYLORI IgA</deviceName>
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    <deviceName>Clarithromycin, Quinolone-Resistant and Non-Resistant Helicobacter Pylori Nucleic Acid Amplification Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-30T06:57:53.413Z</lastUpdated>
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    <udiDi>06970895476034</udiDi>
    <basicUdiDi>B-06970895476034</basicUdiDi>
    <tradeName>06970895476034</tradeName>
    <deviceName>H. Pylori and Multi-Antibiotic Resistance Real-Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010403</emdnCode>
    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B058T050B0C2</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:53.372Z</lastUpdated>
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    <udiDi>06970895475969</udiDi>
    <basicUdiDi>B-06970895475969</basicUdiDi>
    <tradeName>06970895475969</tradeName>
    <deviceName>H. Pylori and Multi-Antibiotic Resistance Real-Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <deviceName>Multi-Antibiotic Resistant H.pylori Strain Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>B055T050B0C2</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:25.754Z</lastUpdated>
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    <basicUdiDi>B-06970895475914</basicUdiDi>
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    <deviceName>Multi-Antibiotic Resistant H.pylori Strain Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301100083000</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:24.554Z</lastUpdated>
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    <deviceName>Clarithromycin, Quinolone-Resistant and Non-Resistant Helicobacter Pylori Nucleic Acid Amplification Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010403</emdnCode>
    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B05201T2048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:14.950Z</lastUpdated>
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    <udiDi>06970895475549</udiDi>
    <basicUdiDi>B-06970895475549</basicUdiDi>
    <tradeName>06970895475549</tradeName>
    <deviceName>H. Pylori and Multi-Antibiotic Resistance Real-Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010403</emdnCode>
    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B05201T2096</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:55:18.502Z</lastUpdated>
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    <udiDi>06970895475518</udiDi>
    <basicUdiDi>B-06970895475518</basicUdiDi>
    <tradeName>06970895475518</tradeName>
    <deviceName>H. Pylori and Multi-Antibiotic Resistance Real-Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010403</emdnCode>
    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B05201T2048</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:55:10.122Z</lastUpdated>
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    <udiDi>06970895474047</udiDi>
    <basicUdiDi>B-06970895474047</basicUdiDi>
    <tradeName>06970895474047</tradeName>
    <deviceName>Helicobacter Pylori (Hp) Antigen Test Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B601T020B0C0</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:54:42.483Z</lastUpdated>
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    <udiDi>06970664752321</udiDi>
    <basicUdiDi>B-06970664752321</basicUdiDi>
    <tradeName>06970664752321</tradeName>
    <deviceName>Helicobacter Pylori Antigen Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25Tests/Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:33:46.976Z</lastUpdated>
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    <udiDi>06956013942346</udiDi>
    <basicUdiDi>B-06956013942346</basicUdiDi>
    <tradeName>06956013942346</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AVE Science &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031214</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:35:41.049Z</lastUpdated>
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    <basicUdiDi>695441470237HD</basicUdiDi>
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    <deviceName>H. pylori Antigen Fast Test Kit (Immunofluorescence Assay)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF1047</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:27:39.477Z</lastUpdated>
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    <tradeName>06952999408845</tradeName>
    <deviceName>One Step H.pylori Antigen Test Device (Feces)</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-602</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:52:11.466Z</lastUpdated>
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    <tradeName>H. pylori Antibody Rapid Test</tradeName>
    <deviceName>H. pylori Antibody Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Format (cassette): A4A411;Format (strip): A4A410</reference>
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    <lastUpdated>2026-06-28T09:33:14.049Z</lastUpdated>
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    <tradeName>H. pylori Antigens Rapid Test</tradeName>
    <deviceName>H. pylori Antigens Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
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    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-28T09:32:32.172Z</lastUpdated>
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    <tradeName>H. pylori Antigens Rapid Test</tradeName>
    <deviceName>H. pylori Antigens Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>H. pylori Antigen Rapid Test</tradeName>
    <deviceName>H. pylori Antigen Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4A412</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:26:57.623Z</lastUpdated>
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