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    <basicUdiDi>697241261IHP-402DR</basicUdiDi>
    <tradeName>LYHER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Laihe Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033566</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-402-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:53:19.678Z</lastUpdated>
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    <udiDi>00630414961644</udiDi>
    <basicUdiDi>0405686901386VV</basicUdiDi>
    <tradeName>IMMULITE 2000 H. pylori IgG</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_H. pylori IgG</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381335</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:49:39.627Z</lastUpdated>
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    <udiDi>D-CI-HPG9K</udiDi>
    <basicUdiDi>B-CI-HPG9K</basicUdiDi>
    <tradeName>Helicobacter pylori(HP) IgG Test Kit(CLIA)</tradeName>
    <deviceName>Helicobacter pylori(HP) IgG Test Kit(CLIA)</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>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CI-HPG</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-20T03:35:42.779Z</lastUpdated>
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    <udiDi>00630414961637</udiDi>
    <basicUdiDi>0405686901386VV</basicUdiDi>
    <tradeName>IMMULITE 2000 H. pylori IgG</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_KIT_H. pylori IgG</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381336</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:15:08.277Z</lastUpdated>
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    <udiDi>D-693757991602QG</udiDi>
    <basicUdiDi>B-693757991602QG</basicUdiDi>
    <tradeName>Diagnostic Kit for Helicobacter pylori antigen (Colloidal Gold)</tradeName>
    <deviceName>Diagnostic Kit for Helicobacter pylori antigen (Colloidal Gold)</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</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>Artık piyasada değil</deviceStatus>
    <reference>HP-Ag501601 HP-Ag251602</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:12.350Z</lastUpdated>
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    <udiDi>D-693757991601QE</udiDi>
    <basicUdiDi>B-693757991601QE</basicUdiDi>
    <tradeName>H.Pylori Antibody (HP) Test</tradeName>
    <deviceName>H.Pylori Antibody (HP) Test</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>HP strip cassette</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:10.366Z</lastUpdated>
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    <udiDi>06952062773283</udiDi>
    <basicUdiDi>B-06952062773283</basicUdiDi>
    <tradeName>H.Pylori Antibody Test Kit</tradeName>
    <deviceName>H.Pylori Antibody Test Kit</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPAb2W-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:56:44.343Z</lastUpdated>
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    <udiDi>06952062773276</udiDi>
    <basicUdiDi>B-06952062773276</basicUdiDi>
    <tradeName>H.Pylori Antibody Test Kit</tradeName>
    <deviceName>H.Pylori Antibody Test Kit</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPAb2W-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:56:42.753Z</lastUpdated>
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    <udiDi>06952062773269</udiDi>
    <basicUdiDi>B-06952062773269</basicUdiDi>
    <tradeName>H.Pylori Antibody Test Kit</tradeName>
    <deviceName>H.Pylori Antibody Test Kit</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPAb2W-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:56:41.961Z</lastUpdated>
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    <udiDi>06952062773252</udiDi>
    <basicUdiDi>B-06952062773252</basicUdiDi>
    <tradeName>H.Pylori Antibody Test Kit</tradeName>
    <deviceName>H.Pylori Antibody Test Kit</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPAb1W-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:56:40.347Z</lastUpdated>
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    <udiDi>06952062773245</udiDi>
    <basicUdiDi>B-06952062773245</basicUdiDi>
    <tradeName>H.Pylori Antibody Test Kit</tradeName>
    <deviceName>H.Pylori Antibody Test Kit</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPAb1W-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:56:36.341Z</lastUpdated>
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    <udiDi>06952062771739</udiDi>
    <basicUdiDi>B-06952062771739</basicUdiDi>
    <tradeName>H.Pylori Antigen Test kit</tradeName>
    <deviceName>H.Pylori Antigen Test kit</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</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>HPAg1FE-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:56:12.271Z</lastUpdated>
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    <udiDi>06952062771722</udiDi>
    <basicUdiDi>B-06952062771722</basicUdiDi>
    <tradeName>H.Pylori Antigen Test kit</tradeName>
    <deviceName>H.Pylori Antigen Test kit</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</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>HPAg2FE-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:56:11.574Z</lastUpdated>
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    <udiDi>04099466111425</udiDi>
    <basicUdiDi>B-04099466111425</basicUdiDi>
    <tradeName>04099466111425</tradeName>
    <deviceName>Serazym® H. pylori 2nd Gen.</deviceName>
    <manufacturerName>Seramun Diagnostica GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026029</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-114</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T12:43:46.615Z</lastUpdated>
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    <udiDi>00816426021150</udiDi>
    <basicUdiDi>B-00816426021150</basicUdiDi>
    <tradeName>K-ASSAY H. pylori Control</tradeName>
    <deviceName>H. pylori Control</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K242C-2M</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:33:00.978Z</lastUpdated>
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    <udiDi>+ENTIPHELG022DS05</udiDi>
    <basicUdiDi>B-+ENTIPHELG022DS05</basicUdiDi>
    <tradeName>+ENTIPHELG022DS05</tradeName>
    <deviceName>NovaLisa® Helicobacter pylori IgG plus</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</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>PHELG022DS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:16:39.227Z</lastUpdated>
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    <udiDi>+ENTIPHELG02207</udiDi>
    <basicUdiDi>B-+ENTIPHELG02207</basicUdiDi>
    <tradeName>+ENTIPHELG02207</tradeName>
    <deviceName>NovaLisa® Helicobacter pylori IgG plus</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>PHELG022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:16:37.623Z</lastUpdated>
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    <deviceName>NovaLisa® Helicobacter pylori IgM</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:14:12.756Z</lastUpdated>
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    <deviceName>NovaLisa® Helicobacter pylori IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <lastUpdated>2026-07-16T10:14:08.567Z</lastUpdated>
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    <tradeName>+ENTIHELG02200P</tradeName>
    <deviceName>NovaLisa® Helicobacter pylori IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <lastUpdated>2026-07-16T10:14:07.674Z</lastUpdated>
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