<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-IZIC-R425FW</udiDi>
    <basicUdiDi>B-IZIC-R425FW</basicUdiDi>
    <tradeName>Zika IgG/IgM and NS1 Combo Rapid Test Cassette</tradeName>
    <deviceName>Zika IgG/IgM and NS1 Combo Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IZIC-R425</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:07:06.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IZIB-R402F5</udiDi>
    <basicUdiDi>B-IZIB-R402F5</basicUdiDi>
    <tradeName>Zika IgG/IgM Rapid Test Cassette</tradeName>
    <deviceName>Zika IgG/IgM Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IZIB-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:07:04.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IRS-R502N7</udiDi>
    <basicUdiDi>B-IRS-R502N7</basicUdiDi>
    <tradeName>RSV Rapid Test Cassette</tradeName>
    <deviceName>RSV Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040605</emdnCode>
    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRS-R502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:03:59.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IRO-R602LQ</udiDi>
    <basicUdiDi>B-IRO-R602LQ</basicUdiDi>
    <tradeName>Rotavirus Rapid Test Cassette</tradeName>
    <deviceName>Rotavirus Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRO-R602</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:03:59.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IRHV-R502J5</udiDi>
    <basicUdiDi>B-IRHV-R502J5</basicUdiDi>
    <tradeName>Rhinovirus Rapid Test</tradeName>
    <deviceName>Rhinovirus Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040620</emdnCode>
    <emdnDescription>RHINOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRHV-R502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:03:55.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IPIV-R502HG</udiDi>
    <basicUdiDi>B-IPIV-R502HG</basicUdiDi>
    <tradeName>HPIV Rapid Test</tradeName>
    <deviceName>HPIV Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPIV-R502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:03:54.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-COV-S8293</udiDi>
    <basicUdiDi>B-CNMF000014455-COV-S8293</basicUdiDi>
    <tradeName>D-CNMF000014455-COV-S8293</tradeName>
    <deviceName>SARS-CoV-2 Neutralizing  Antibodies Test Kit (Lateral Flow Assay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-S82</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:12.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-COV-S418M</udiDi>
    <basicUdiDi>B-CNMF000014455-COV-S418M</basicUdiDi>
    <tradeName>D-CNMF000014455-COV-S418M</tradeName>
    <deviceName>SARS-CoV-2 Neutralizing  Antibodies Test Kit (Enzyme Linked  Immunosorbent Assay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-S41</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:10.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-COV-S728Y</udiDi>
    <basicUdiDi>B-CNMF000014455-COV-S728Y</basicUdiDi>
    <tradeName>D-CNMF000014455-COV-S728Y</tradeName>
    <deviceName>SARS-CoV-2 Antigen Test (Lateral Flow Assay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-S72</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:05.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-COV-S818Z</udiDi>
    <basicUdiDi>B-CNMF000014455-COV-S818Z</basicUdiDi>
    <tradeName>D-CNMF000014455-COV-S818Z</tradeName>
    <deviceName>SARS-CoV-2 Neutralizing  Antibodies Test Kit (Lateral Flow Assay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-S81</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:03.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-COV-S718W</udiDi>
    <basicUdiDi>B-CNMF000014455-COV-S718W</basicUdiDi>
    <tradeName>D-CNMF000014455-COV-S718W</tradeName>
    <deviceName>SARS-CoV-2 Antigen Test (Lateral Flow Assay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-S71</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:55:58.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-COV-S618T</udiDi>
    <basicUdiDi>B-CNMF000014455-COV-S618T</basicUdiDi>
    <tradeName>D-CNMF000014455-COV-S618T</tradeName>
    <deviceName>SARS-CoV-2 Antigen Test (Lateral Flow Assay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-S61</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:55:51.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-COV-S528S</udiDi>
    <basicUdiDi>B-CNMF000014455-COV-S528S</basicUdiDi>
    <tradeName>D-CNMF000014455-COV-S528S</tradeName>
    <deviceName>SARS-CoV-2 Neutralizing  Antibodies Test Kit (Lateral Flow Assay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-S52</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:55:49.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-COV-S518Q</udiDi>
    <basicUdiDi>B-CNMF000014455-COV-S518Q</basicUdiDi>
    <tradeName>D-CNMF000014455-COV-S518Q</tradeName>
    <deviceName>SARS-CoV-2 Neutralizing  Antibodies Test Kit (Lateral Flow Assay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-S51</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:55:48.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-COV-S318J</udiDi>
    <basicUdiDi>B-CNMF000014455-COV-S318J</basicUdiDi>
    <tradeName>D-CNMF000014455-COV-S318J</tradeName>
    <deviceName>SARS-CoV-2 Antigen Test (Lateral Flow Assay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-S31</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:55:40.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A045D5</udiDi>
    <basicUdiDi>B-A045D5</basicUdiDi>
    <tradeName>D-A045D5</tradeName>
    <deviceName>INDICAID™ Hand Foot And Mouth Disease Rapid Antibody Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040602</emdnCode>
    <emdnDescription>ENTEROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Hand Foot And Mouth Disease Rapid Antibody Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:42:48.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840313222</udiDi>
    <basicUdiDi>B-69743840313222</basicUdiDi>
    <tradeName>RSV Antigen Rapid Test（Swab）</tradeName>
    <deviceName>RSV Antigen Rapid Test（Swab）</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040605</emdnCode>
    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3022001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:13:25.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840311242</udiDi>
    <basicUdiDi>B-69743840311242</basicUdiDi>
    <tradeName>Zika Rapid Test</tradeName>
    <deviceName>Zika Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3023903</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:36.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840310870</udiDi>
    <basicUdiDi>B-69743840310870</basicUdiDi>
    <tradeName>Parvovirus antigen（CPV Ag/FPV Ag） Rapid Test</tradeName>
    <deviceName>Parvovirus antigen（CPV Ag/FPV Ag） Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040609</emdnCode>
    <emdnDescription>PARVOVIRUS B 19</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3027601</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:31.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840309430</udiDi>
    <basicUdiDi>B-69743840309430</basicUdiDi>
    <tradeName>Dengue NS1 Antigen &amp; IgG/IgM Rapid Test（Whole Blood/Serum/Plasma）</tradeName>
    <deviceName>Dengue NS1 Antigen &amp; IgG/IgM Rapid Test（Whole Blood/Serum/Plasma）</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3021303</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:11:42.780Z</lastUpdated>
  </row>
</eudamedExport>