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<eudamedExport entity="devices">
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    <basicUdiDi>B-06971792050051</basicUdiDi>
    <tradeName>Novel Coronavirus（SARS-Cov-2）Antigen Rapid Test Device（saliva）</tradeName>
    <deviceName>Novel Coronavirus（SARS-Cov-2）Antigen Rapid Test Device（saliva）</deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K590516D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:52:13.081Z</lastUpdated>
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  <row>
    <udiDi>06971792050037</udiDi>
    <basicUdiDi>B-06971792050037</basicUdiDi>
    <tradeName>Novel Coronavirus (SARS-Cov-2)  Antigen Rapid Test Device (nasal swab)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K601416D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:52:09.868Z</lastUpdated>
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    <udiDi>06971390439999</udiDi>
    <basicUdiDi>B-06971390439999</basicUdiDi>
    <tradeName>HOKAPI™ SARS-CoV-2 IgM</tradeName>
    <deviceName>HOKAPI™ SARS-CoV-2 IgM</deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010220101</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:56:45.477Z</lastUpdated>
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    <udiDi>06971390439975</udiDi>
    <basicUdiDi>B-06971390439975</basicUdiDi>
    <tradeName>HOKAPI™ SARS-CoV-2 IgG</tradeName>
    <deviceName>HOKAPI™ SARS-CoV-2 IgG</deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010219101</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:56:43.724Z</lastUpdated>
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    <udiDi>06971042229657</udiDi>
    <basicUdiDi>B-06971042229657</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Detection Kit (Colloidal Gold)</tradeName>
    <deviceName>SARS-CoV-2 Antigen Detection Kit (Colloidal Gold)</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG-0003-20</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:48.091Z</lastUpdated>
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  <row>
    <udiDi>06971042229640</udiDi>
    <basicUdiDi>B-06971042229640</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Detection Kit (Colloidal Gold)</tradeName>
    <deviceName>SARS-CoV-2 Antigen Detection Kit (Colloidal Gold)</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG-0003-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:46.496Z</lastUpdated>
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    <udiDi>06971042229626</udiDi>
    <basicUdiDi>B-06971042229626</basicUdiDi>
    <tradeName>SARS-CoV-2 Neutralization Antibody Detection Kit (ELISA),</tradeName>
    <deviceName>SARS-CoV-2 Neutralization Antibody Detection Kit (ELISA),</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-0001-96</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:46.118Z</lastUpdated>
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  <row>
    <udiDi>06971042229633</udiDi>
    <basicUdiDi>B-06971042229633</basicUdiDi>
    <tradeName>SARS-CoV-2 Neutralization Antibody Detection Kit (Colloidal Gold),</tradeName>
    <deviceName>SARS-CoV-2 Neutralization Antibody Detection Kit (Colloidal Gold),</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG-0004-20</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:46.074Z</lastUpdated>
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  <row>
    <udiDi>06971042229589</udiDi>
    <basicUdiDi>B-06971042229589</basicUdiDi>
    <tradeName>Liferiver SARS-CoV-2 484A Mutation Detection Kit</tradeName>
    <deviceName>Liferiver SARS-CoV-2 484A Mutation Detection Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RR-0506-02-25</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:38.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971042229541</udiDi>
    <basicUdiDi>B-06971042229541</basicUdiDi>
    <tradeName>Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Detection Kit (Colloidal Gold)</tradeName>
    <deviceName>Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Detection Kit (Colloidal Gold)</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>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG-0002-20</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:32.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971042229534</udiDi>
    <basicUdiDi>B-06971042229534</basicUdiDi>
    <tradeName>Novel Coronavirus (SARS-CoV-2) Antigen and Antibody Assay kit</tradeName>
    <deviceName>Novel Coronavirus (SARS-CoV-2) Antigen and Antibody Assay 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>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG-0001-20</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:06:29.775Z</lastUpdated>
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  <row>
    <udiDi>06971042229381</udiDi>
    <basicUdiDi>B-06971042229381</basicUdiDi>
    <tradeName>Hantavirus Renal Syndrome Type II  Real Time RT-PCR Kit</tradeName>
    <deviceName>Hantavirus Renal Syndrome Type II  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>W0105040614</emdnCode>
    <emdnDescription>HANTAVIRUS / BUNYAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QR-0236-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:04:23.361Z</lastUpdated>
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  <row>
    <udiDi>06952062780786</udiDi>
    <basicUdiDi>B-06952062780786</basicUdiDi>
    <tradeName>Noroviruses Antigen Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Noroviruses Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040616</emdnCode>
    <emdnDescription>NOROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NV1FE-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:32:14.276Z</lastUpdated>
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  <row>
    <udiDi>06936983126199</udiDi>
    <basicUdiDi>B-06936983126199</basicUdiDi>
    <tradeName>Prueba Rápida Combinada de Rotavirus y Adenovirus en Casete</tradeName>
    <deviceName>Prueba Rápida Combinada de Rotavirus y Adenovirus en Casete</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>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRAC-625</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:19:58.815Z</lastUpdated>
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    <udiDi>06936983126182</udiDi>
    <basicUdiDi>B-06936983126182</basicUdiDi>
    <tradeName>"Prueba Rápida Combinada de Rotavirus y Adenovirus en Casete "</tradeName>
    <deviceName>Prueba Rápida Combinada de Rotavirus y Adenovirus en Casete</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>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRAC-625</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:19:58.021Z</lastUpdated>
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    <udiDi>04260163316035</udiDi>
    <basicUdiDi>B-04260163316035</basicUdiDi>
    <tradeName>Rapid Dengue NS1 Antigen Test Card</tradeName>
    <deviceName>Rapid Dengue NS1 Antigen Test Card</deviceName>
    <manufacturerName>MP Biomedicals Germany GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020991</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07DEN025AG</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:51:25.811Z</lastUpdated>
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    <udiDi>04050598013377</udiDi>
    <basicUdiDi>B-04050598013377</basicUdiDi>
    <tradeName>PreventID® Influenza A+B</tradeName>
    <deviceName>PreventID® Influenza A+B</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KST50112GP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:50:15.067Z</lastUpdated>
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    <udiDi>04049325004665</udiDi>
    <basicUdiDi>B-04049325004665</basicUdiDi>
    <tradeName>TBE virus (FSME) IgG ELISA</tradeName>
    <deviceName>TBE virus (FSME) IgG ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040612</emdnCode>
    <emdnDescription>FSME VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE57401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:10:09.405Z</lastUpdated>
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    <udiDi>03770011742660</udiDi>
    <basicUdiDi>B-03770011742660</basicUdiDi>
    <tradeName>TROD'DENGUE</tradeName>
    <deviceName>TROD'DENGUE</deviceName>
    <manufacturerName>AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL</manufacturerName>
    <manufacturerSrn>FR-MF-000015889</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TR-DEN-002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:22:13.646Z</lastUpdated>
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    <udiDi>03770011742318</udiDi>
    <basicUdiDi>B-03770011742318</basicUdiDi>
    <tradeName>ALL IN DUO</tradeName>
    <deviceName>ALL IN DUO</deviceName>
    <manufacturerName>AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL</manufacturerName>
    <manufacturerSrn>FR-MF-000015889</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TR-COG-002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:22:07.229Z</lastUpdated>
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