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    <basicUdiDi>69506174IM440017D5</basicUdiDi>
    <tradeName>06950617420255</tradeName>
    <deviceName>HEV IgG Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEV ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4492017</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:46:54.022Z</lastUpdated>
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  <row>
    <udiDi>06950617416333</udiDi>
    <basicUdiDi>69506174IM440010CP</basicUdiDi>
    <tradeName>06950617416333</tradeName>
    <deviceName>HAV IgM Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4401010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:52.762Z</lastUpdated>
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    <udiDi>06950617416326</udiDi>
    <basicUdiDi>69506174IM440010CP</basicUdiDi>
    <tradeName>06950617416326</tradeName>
    <deviceName>HAV IgM Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:51.563Z</lastUpdated>
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    <udiDi>06950617416265</udiDi>
    <basicUdiDi>69506174IM440010CP</basicUdiDi>
    <tradeName>06950617416265</tradeName>
    <deviceName>HAV IgM Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:50.377Z</lastUpdated>
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  <row>
    <udiDi>06950617415855</udiDi>
    <basicUdiDi>69506174IM440017D5</basicUdiDi>
    <tradeName>06950617415855</tradeName>
    <deviceName>HEV IgG Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEV ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402017</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:49.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617415824</udiDi>
    <basicUdiDi>69506174IM440017D5</basicUdiDi>
    <tradeName>06950617415824</tradeName>
    <deviceName>HEV IgG Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEV ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403017</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:43.154Z</lastUpdated>
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  <row>
    <udiDi>06950617415800</udiDi>
    <basicUdiDi>69506174IM440017D5</basicUdiDi>
    <tradeName>06950617415800</tradeName>
    <deviceName>HEV IgG Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEV ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406017</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:41.956Z</lastUpdated>
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  <row>
    <udiDi>06950617410850</udiDi>
    <basicUdiDi>69506174IM440010CP</basicUdiDi>
    <tradeName>06950617410850</tradeName>
    <deviceName>HAV IgM Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4405010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:04.747Z</lastUpdated>
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    <udiDi>06950617410843</udiDi>
    <basicUdiDi>69506174IM440017D5</basicUdiDi>
    <tradeName>06950617410843</tradeName>
    <deviceName>HEV IgG Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEV ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407017</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:03.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145505516</udiDi>
    <basicUdiDi>B-06947145505516</basicUdiDi>
    <tradeName>MAGLUMI HAV IgM (CLIA)</tradeName>
    <deviceName>HAV IgM (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130210008M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:18:03.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145505493</udiDi>
    <basicUdiDi>B-06947145505493</basicUdiDi>
    <tradeName>MAGLUMI Anti-HAV (CLIA)</tradeName>
    <deviceName>Anti-HAV (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130210007M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:17:56.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936983106009</udiDi>
    <basicUdiDi>B-06936983106009</basicUdiDi>
    <tradeName>HCV Rapid Test</tradeName>
    <deviceName></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 Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHC-402</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:55:46.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155807147</udiDi>
    <basicUdiDi>B-06936155807147</basicUdiDi>
    <tradeName>Rapid Anti-HEV-IgM Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP091101-DS50</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:14:23.500Z</lastUpdated>
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  <row>
    <udiDi>06936155804313</udiDi>
    <basicUdiDi>B-06936155804313</basicUdiDi>
    <tradeName>06936155804313</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ITP01153-TC40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:09.019Z</lastUpdated>
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  <row>
    <udiDi>06936155804306</udiDi>
    <basicUdiDi>B-06936155804306</basicUdiDi>
    <tradeName>06936155804306</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP01153-TC10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:07.901Z</lastUpdated>
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  <row>
    <udiDi>06936155804290</udiDi>
    <basicUdiDi>B-06936155804290</basicUdiDi>
    <tradeName>06936155804290</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP01152-TC40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:05.436Z</lastUpdated>
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  <row>
    <udiDi>06936155804283</udiDi>
    <basicUdiDi>B-06936155804283</basicUdiDi>
    <tradeName>06936155804283</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ITP01152-TC25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:04.234Z</lastUpdated>
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  <row>
    <udiDi>06936155803712</udiDi>
    <basicUdiDi>B-06936155803712</basicUdiDi>
    <tradeName>Rapid Anti-HEV-IgM Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP091101-TC40</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:12:35.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414592213</udiDi>
    <basicUdiDi>0405686901502V7</basicUdiDi>
    <tradeName>ADVIA Centaur Quantitative HBsAg (QHBs)</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020201</emdnCode>
    <emdnDescription>HEPATITIS B SURFACE ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10699087</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:35:38.725Z</lastUpdated>
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  <row>
    <udiDi>04262353370087</udiDi>
    <basicUdiDi>B-04262353370087</basicUdiDi>
    <tradeName>PoET HEV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gesellschaft zur Forschung, Entwicklung  und Distribution von Diagnostika  im Blutspendewesen mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025295</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2F-28-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:44:22.388Z</lastUpdated>
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