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    <tradeName>H.Pylori Antibody Rapid Test Cassette(Colloidal Gold)</tradeName>
    <deviceName>H.Pylori Antibody Rapid Test Cassette(Colloidal Gold)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</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>GKPD023</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:28:03.544Z</lastUpdated>
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    <udiDi>06977565583948</udiDi>
    <basicUdiDi>B-06977565583948</basicUdiDi>
    <tradeName>H.Pylori Antigen Rapid Detection Test</tradeName>
    <deviceName>H.Pylori Antigen Rapid Detection Test</deviceName>
    <manufacturerName>Coei Biotech Co.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049509</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3942</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:22:23.699Z</lastUpdated>
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    <udiDi>06976753475416</udiDi>
    <basicUdiDi>B-06976753475416</basicUdiDi>
    <tradeName>H. pylori Antigen Rapid Test Strip(Feces)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</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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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:00:06.710Z</lastUpdated>
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    <udiDi>06976753474457</udiDi>
    <basicUdiDi>B-06976753474457</basicUdiDi>
    <tradeName>H.Pylori(HP) Antibody Rapid Test Device (whole blood/serum/plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D070501D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:59:03.448Z</lastUpdated>
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    <udiDi>06976753474426</udiDi>
    <basicUdiDi>B-06976753474426</basicUdiDi>
    <tradeName>H.Pylori Antigen Rapid Test Device (feces)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D060401D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:59:02.589Z</lastUpdated>
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    <udiDi>06975068490374</udiDi>
    <basicUdiDi>B-06975068490374</basicUdiDi>
    <tradeName>Helicobacter Pylori（HP）Antigen Rapid Quantitative Test（Fluorescence Immunoassay）</tradeName>
    <deviceName>Helicobacter Pylori（HP）Antigen Rapid Quantitative Test（Fluorescence Immunoassay）</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP083.B1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:30:36.182Z</lastUpdated>
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    <udiDi>06974912093860</udiDi>
    <basicUdiDi>B-06974912093860</basicUdiDi>
    <tradeName>POCBio H.Pylori Antigen Rapid Test</tradeName>
    <deviceName>POCBio H.Pylori Antigen Rapid Test</deviceName>
    <manufacturerName>Nexlab Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047094</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LATG02-C25</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:02:26.003Z</lastUpdated>
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    <udiDi>06974854620599</udiDi>
    <basicUdiDi>B-06974854620599</basicUdiDi>
    <tradeName>Gastric Helicobacter pylori (HP) polypeptide antigen Test kit</tradeName>
    <deviceName>Gastric Helicobacter pylori (HP) polypeptide antigen Test kit</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2201125</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:52:55.439Z</lastUpdated>
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    <udiDi>06974735360880</udiDi>
    <basicUdiDi>B-06974735360880</basicUdiDi>
    <tradeName>KEYU H. Pylori Rapid Rapid Test (Colloidal Gold)</tradeName>
    <deviceName>H. Pylori Rapid Rapid Test (Colloidal Gold)</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-R-G</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:33:47.279Z</lastUpdated>
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    <udiDi>06974735360781</udiDi>
    <basicUdiDi>B-06974735360781</basicUdiDi>
    <tradeName>KEYU H. Pylori Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>H. Pylori Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</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>HP-I</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:33:35.262Z</lastUpdated>
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    <udiDi>06974735360644</udiDi>
    <basicUdiDi>B-06974735360644</basicUdiDi>
    <tradeName>KEYU H. Pylori Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>H. Pylori Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</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>HP-III</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:33:23.252Z</lastUpdated>
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    <udiDi>06974735360415</udiDi>
    <basicUdiDi>B-06974735360415</basicUdiDi>
    <tradeName>KEYU H. Pylori Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>H. Pylori Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</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>HP-II</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:32:45.576Z</lastUpdated>
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    <udiDi>06974735360217</udiDi>
    <basicUdiDi>B-06974735360217</basicUdiDi>
    <tradeName>KEYU H. Pylori Rapid Rapid Test (Colloidal Gold)</tradeName>
    <deviceName>H. Pylori Rapid Rapid Test (Colloidal Gold)</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-R-F</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:32:31.172Z</lastUpdated>
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    <udiDi>06974674892374</udiDi>
    <basicUdiDi>B-06974674892374</basicUdiDi>
    <tradeName>H. Pylori Ag FIA Kit</tradeName>
    <deviceName>H. Pylori Ag FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0067</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:17.771Z</lastUpdated>
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    <udiDi>06974323019619</udiDi>
    <basicUdiDi>B-06974323019619</basicUdiDi>
    <tradeName>06974323019619</tradeName>
    <deviceName>Helicobacter Pylori Antigen Rapid 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>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:06:13.091Z</lastUpdated>
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    <udiDi>06974323019602</udiDi>
    <basicUdiDi>B-06974323019602</basicUdiDi>
    <tradeName>06974323019602</tradeName>
    <deviceName>Helicobacter Pylori Antigen Rapid 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>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:06:12.845Z</lastUpdated>
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    <basicUdiDi>B-06974323019596</basicUdiDi>
    <tradeName>06974323019596</tradeName>
    <deviceName>Helicobacter Pylori Antigen Rapid 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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    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:04:20.479Z</lastUpdated>
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    <udiDi>06974238910407</udiDi>
    <basicUdiDi>B-06974238910407</basicUdiDi>
    <tradeName>H. pylori Antigen Rapid Test</tradeName>
    <deviceName></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>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HHP033G</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:58:33.318Z</lastUpdated>
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    <basicUdiDi>B-06973861683542</basicUdiDi>
    <tradeName>HP Rapid Test Kit</tradeName>
    <deviceName>HP Rapid Test Kit</deviceName>
    <manufacturerName>Anbio (Xiamen) Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023936</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>A02081002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:41:56.589Z</lastUpdated>
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    <udiDi>06973181850440</udiDi>
    <basicUdiDi>B-06973181850440</basicUdiDi>
    <tradeName>StrongStep® H.pylori Antigen Rapid Test</tradeName>
    <deviceName>H.pylori Antigen Rapid Test</deviceName>
    <manufacturerName>Nanjing Liming Bio-products Co. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041298</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>501040</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:52:32.524Z</lastUpdated>
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