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<eudamedExport entity="devices">
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    <udiDi>D-GKPD198Y9</udiDi>
    <basicUdiDi>B-GKPD198Y9</basicUdiDi>
    <tradeName>Human β - amyloid protein (Aβ1-42)  Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>Human β - amyloid protein (Aβ1-42)  Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD198</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:40:17.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD145XL</udiDi>
    <basicUdiDi>B-GKPD145XL</basicUdiDi>
    <tradeName>Human β - amyloid protein (Aβ1-42)  Rapid Test Kit</tradeName>
    <deviceName>Human β - amyloid protein (Aβ1-42)  Rapid Test Kit</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD145</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:27.141Z</lastUpdated>
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  <row>
    <udiDi>D-CQ5771023F</udiDi>
    <basicUdiDi>B-CQ5771023F</basicUdiDi>
    <tradeName>D-CQ5771023F</tradeName>
    <deviceName>HISCL β-Amyloid 1-42 Assay kit</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CQ577102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:20:00.004Z</lastUpdated>
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  <row>
    <udiDi>06975531323376</udiDi>
    <basicUdiDi>B-06975531323376</basicUdiDi>
    <tradeName>06975531323376</tradeName>
    <deviceName>Human Beta-amyloid (ABeta) test kit (Lateral flow immunochromatography assay)</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:23.207Z</lastUpdated>
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  <row>
    <udiDi>06975531323369</udiDi>
    <basicUdiDi>B-06975531323369</basicUdiDi>
    <tradeName>06975531323369</tradeName>
    <deviceName>Human Beta-amyloid (ABeta) test kit (Lateral flow immunochromatography assay)</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:22.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975531323345</udiDi>
    <basicUdiDi>B-06975531323345</basicUdiDi>
    <tradeName>06975531323345</tradeName>
    <deviceName>Human Beta-amyloid (ABeta) test kit (Lateral flow immunochromatography assay)</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:16.807Z</lastUpdated>
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  <row>
    <udiDi>06974738205263</udiDi>
    <basicUdiDi>B-06974738205263</basicUdiDi>
    <tradeName>Amyloid Beta (1-42) Rapid Test Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Fluorescence Immunochromatography Analyzer</deviceName>
    <manufacturerName>Hoyotek Biomedical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003570</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF21-01-40</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:38:28.796Z</lastUpdated>
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  <row>
    <udiDi>06974738205256</udiDi>
    <basicUdiDi>B-06974738205256</basicUdiDi>
    <tradeName>Amyloid Beta (1-42) Rapid Test Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Fluorescence Immunochromatography Analyzer</deviceName>
    <manufacturerName>Hoyotek Biomedical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003570</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF21-01-20</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:38:27.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521001041</udiDi>
    <basicUdiDi>B-06974521001041</basicUdiDi>
    <tradeName>Aβ1-42 Assay kit CLIA</tradeName>
    <deviceName>Aβ1-42 Assay kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM091072</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:29:02.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974521001034</udiDi>
    <basicUdiDi>B-06974521001034</basicUdiDi>
    <tradeName>Aβ1-42 Assay kit CLIA</tradeName>
    <deviceName>Aβ1-42 Assay kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM091036</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:29:01.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974464591517</udiDi>
    <basicUdiDi>B-06974464591517</basicUdiDi>
    <tradeName>Serum Amyloid A (SAA) Rapid Test Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Serum Amyloid A (SAA) Rapid Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Guangzhou Decheng Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013536</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5064C4X025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:09:19.073Z</lastUpdated>
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  <row>
    <udiDi>06972719605385</udiDi>
    <basicUdiDi>B-06972719605385</basicUdiDi>
    <tradeName>06972719605385</tradeName>
    <deviceName>Amyloid β Protein 1-42 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:49:49.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719605378</udiDi>
    <basicUdiDi>B-06972719605378</basicUdiDi>
    <tradeName>06972719605378</tradeName>
    <deviceName>Amyloid β Protein 1-42 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:49:33.582Z</lastUpdated>
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  <row>
    <udiDi>06972719603312</udiDi>
    <basicUdiDi>B-06972719603312</basicUdiDi>
    <tradeName>06972719603312</tradeName>
    <deviceName>Amyloid β Protein 1-42 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:42:33.525Z</lastUpdated>
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  <row>
    <udiDi>06972719603305</udiDi>
    <basicUdiDi>B-06972719603305</basicUdiDi>
    <tradeName>06972719603305</tradeName>
    <deviceName>Amyloid β Protein 1-42 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:42:31.124Z</lastUpdated>
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  <row>
    <udiDi>06972719603299</udiDi>
    <basicUdiDi>B-06972719603299</basicUdiDi>
    <tradeName>06972719603299</tradeName>
    <deviceName>Amyloid β Protein 1-42 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:42:29.526Z</lastUpdated>
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  <row>
    <udiDi>06972719601424</udiDi>
    <basicUdiDi>B-06972719601424</basicUdiDi>
    <tradeName>06972719601424</tradeName>
    <deviceName>Amyloid β Protein 1-42 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019014</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-42)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:36:37.357Z</lastUpdated>
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