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    <udiDi>06974323018322</udiDi>
    <basicUdiDi>B-06974323018322</basicUdiDi>
    <tradeName>06974323018322</tradeName>
    <deviceName>Hepatitis E Virus IgM Antibody Rapid Test Cassette (Colloidal Gold 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>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IH008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:01:36.221Z</lastUpdated>
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  <row>
    <udiDi>06974323010869</udiDi>
    <basicUdiDi>B-06974323010869</basicUdiDi>
    <tradeName>06974323010869</tradeName>
    <deviceName>Real-time PCR Detection Kit for Hepatitis E Virus</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>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:43:48.653Z</lastUpdated>
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    <udiDi>06974323010852</udiDi>
    <basicUdiDi>B-06974323010852</basicUdiDi>
    <tradeName>06974323010852</tradeName>
    <deviceName>Real-time PCR Detection Kit for Hepatitis E Virus</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>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:43:47.046Z</lastUpdated>
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    <udiDi>06973914380435</udiDi>
    <basicUdiDi>B-06973914380435</basicUdiDi>
    <tradeName>06973914380435</tradeName>
    <deviceName>Hepatitis E virus(HEV) IgG Antibody Detection Kit (Magnetic Particle CLIA)</deviceName>
    <manufacturerName>Tianjin Bioscience Diagnostic Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023301</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEV ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H201.02.021C1.01X</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:47:00.676Z</lastUpdated>
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    <udiDi>06971042229060</udiDi>
    <basicUdiDi>B-06971042229060</basicUdiDi>
    <tradeName>HEV General Type Real Time RT-PCR Kit</tradeName>
    <deviceName>HEV General Type Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR-0307-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:03:19.272Z</lastUpdated>
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  <row>
    <udiDi>06971042229053</udiDi>
    <basicUdiDi>B-06971042229053</basicUdiDi>
    <tradeName>HEV I &amp;III Real Time RT-PCR Kit</tradeName>
    <deviceName>HEV I &amp;III Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR-0228-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:03:18.467Z</lastUpdated>
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    <udiDi>06971042229039</udiDi>
    <basicUdiDi>B-06971042229039</basicUdiDi>
    <tradeName>HEV Real Time RT-PCR Kit</tradeName>
    <deviceName>HEV Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR-0011-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:03:14.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>08685115805478</udiDi>
    <basicUdiDi>868511580PCR43JC</basicUdiDi>
    <tradeName>LyoSens  HEV qPCR Kit</tradeName>
    <deviceName>HEV qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCR43</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:36:28.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595033456</udiDi>
    <basicUdiDi>868511580PCR43JC</basicUdiDi>
    <tradeName>ChainFor HEV qPCR Kit</tradeName>
    <deviceName>HEV qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCR43</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:30:09.871Z</lastUpdated>
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  <row>
    <udiDi>06970301452560</udiDi>
    <basicUdiDi>B-06970301452560</basicUdiDi>
    <tradeName>06970301452560</tradeName>
    <deviceName>Rapid Test for IgM Antibody to Hepatitis E Virus (Colloidal Gold Device)</deviceName>
    <manufacturerName>Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040626</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WE-1510</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:26:18.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970301452546</udiDi>
    <basicUdiDi>B-06970301452546</basicUdiDi>
    <tradeName>06970301452546</tradeName>
    <deviceName>WANTAI HEV-Ag ELISA Plus</deviceName>
    <manufacturerName>Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040626</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020501</emdnCode>
    <emdnDescription>HEV ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WE-7596</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:26:11.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970301452539</udiDi>
    <basicUdiDi>B-06970301452539</basicUdiDi>
    <tradeName>06970301452539</tradeName>
    <deviceName>WANTAI HEV-IgG ELISA</deviceName>
    <manufacturerName>Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040626</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEV ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WE-7296</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:26:10.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970301452522</udiDi>
    <basicUdiDi>B-06970301452522</basicUdiDi>
    <tradeName>06970301452522</tradeName>
    <deviceName>WANTAI HEV-IgM ELISA</deviceName>
    <manufacturerName>Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040626</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WE-7196</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:26:09.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053049184</udiDi>
    <basicUdiDi>69449040AB74000415J</basicUdiDi>
    <tradeName>Hepatitis E Virus IgM Antibody (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-038867-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:31.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053049320</udiDi>
    <basicUdiDi>69449040AB74000425L</basicUdiDi>
    <tradeName>Hepatitis E Virus IgG Antibody (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEV ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-038864-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:31.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053074834</udiDi>
    <basicUdiDi>69449040AB74000425L</basicUdiDi>
    <tradeName>HEV IgG Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-045975-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:14.351Z</lastUpdated>
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    <udiDi>06903053074865</udiDi>
    <basicUdiDi>69449040AB74000425L</basicUdiDi>
    <tradeName>HEV IgG Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-045976-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:14.288Z</lastUpdated>
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  <row>
    <udiDi>06903053074889</udiDi>
    <basicUdiDi>69449040AB74000425L</basicUdiDi>
    <tradeName>HEV IgG Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-045978-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:14.252Z</lastUpdated>
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  <row>
    <udiDi>06903053074902</udiDi>
    <basicUdiDi>69449040AB74000425L</basicUdiDi>
    <tradeName>HEV IgG Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-045977-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:14.218Z</lastUpdated>
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    <udiDi>06950617420255</udiDi>
    <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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