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<eudamedExport entity="devices">
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    <udiDi>06976202762500</udiDi>
    <basicUdiDi>B-06976202762500</basicUdiDi>
    <tradeName>HEV IgM Rapid Test</tradeName>
    <deviceName>HEV IgM Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIHEVm-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:37:15.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762081</udiDi>
    <basicUdiDi>B-06976202762081</basicUdiDi>
    <tradeName>HAV IgG/IgM Rapid Test</tradeName>
    <deviceName>HAV IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIHAVb-422</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:36:13.643Z</lastUpdated>
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  <row>
    <udiDi>06974854620780</udiDi>
    <basicUdiDi>B-06974854620780</basicUdiDi>
    <tradeName>HAV lgM Rapid Test</tradeName>
    <deviceName>HAV lgM Rapid Test</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>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2202825</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:53:21.857Z</lastUpdated>
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    <udiDi>06974854620735</udiDi>
    <basicUdiDi>B-06974854620735</basicUdiDi>
    <tradeName>HAV Ag One Step Rapid Test</tradeName>
    <deviceName>HAV Ag One Step Rapid Test</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>W0105020101</emdnCode>
    <emdnDescription>HAV ANTIGEN CONFIRMATORY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2202325</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:53:14.657Z</lastUpdated>
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  <row>
    <udiDi>06974323018346</udiDi>
    <basicUdiDi>B-06974323018346</basicUdiDi>
    <tradeName>06974323018346</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>2026-07-06T16:01:55.494Z</lastUpdated>
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  <row>
    <udiDi>06974323018339</udiDi>
    <basicUdiDi>B-06974323018339</basicUdiDi>
    <tradeName>06974323018339</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>2026-07-06T16:01:51.498Z</lastUpdated>
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  <row>
    <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>06974323018315</udiDi>
    <basicUdiDi>B-06974323018315</basicUdiDi>
    <tradeName>06974323018315</tradeName>
    <deviceName>Hepatitis A 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>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IH007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:01:35.424Z</lastUpdated>
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  <row>
    <udiDi>06974323018308</udiDi>
    <basicUdiDi>B-06974323018308</basicUdiDi>
    <tradeName>06974323018308</tradeName>
    <deviceName>Hepatitis A 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>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IH007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:01:34.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323018292</udiDi>
    <basicUdiDi>B-06974323018292</basicUdiDi>
    <tradeName>06974323018292</tradeName>
    <deviceName>Hepatitis A 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>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IH007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:01:30.621Z</lastUpdated>
  </row>
  <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>06974323010807</udiDi>
    <basicUdiDi>B-06974323010807</basicUdiDi>
    <tradeName>06974323010807</tradeName>
    <deviceName>Real-Time PCR Detection Kit for Hepatitis A 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>W0105020105</emdnCode>
    <emdnDescription>HEPATITIS A VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID039</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:43:46.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973914380442</udiDi>
    <basicUdiDi>B-06973914380442</basicUdiDi>
    <tradeName>06973914380442</tradeName>
    <deviceName>Hepatitis A virus （HAV）IgM 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>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H201.02.107C1.01X</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:47:01.473Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <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>
  </row>
  <row>
    <udiDi>06971042229046</udiDi>
    <basicUdiDi>B-06971042229046</basicUdiDi>
    <tradeName>HGV Real Time RT-PCR Kit</tradeName>
    <deviceName>HGV 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>W0105020606</emdnCode>
    <emdnDescription>HEPATITIS G VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR-0012-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:03:16.874Z</lastUpdated>
  </row>
  <row>
    <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>06971042229022</udiDi>
    <basicUdiDi>B-06971042229022</basicUdiDi>
    <tradeName>HAV Real Time RT-PCR Kit</tradeName>
    <deviceName>HAV 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>W0105020105</emdnCode>
    <emdnDescription>HEPATITIS A VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR-0001-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:03:12.875Z</lastUpdated>
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</eudamedExport>