<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ZIKANS1-W23YD</udiDi>
    <basicUdiDi>B-ZIKANS1-W23YD</basicUdiDi>
    <tradeName>D-ZIKANS1-W23YD</tradeName>
    <deviceName>Zika NS1 Antigen Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZIKA-NS1-W23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:12:40.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ZIKA-D22aHA</udiDi>
    <basicUdiDi>B-ZIKA-D22aHA</basicUdiDi>
    <tradeName>Zika IgG/lgM Antibody Rapid Test</tradeName>
    <deviceName>Zika IgG/lgM Antibody Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZIKA-D22a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:12:37.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MPXV-C91-25MN</udiDi>
    <basicUdiDi>B-WI-MPXV-C91-25MN</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>Monkeypox Virus Antigen Rapid Test Device (Pus Swab)</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WI-MPXV-C91-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:32:30.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MPXV-C42-25L6</udiDi>
    <basicUdiDi>B-WI-MPXV-C42-25L6</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>Monkeypox Virus IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WI-MPXV-C42-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:32:28.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MICR-C86A-25CQ</udiDi>
    <basicUdiDi>B-WI-MICR-C86A-25CQ</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>FLU A/B &amp; SARS-Cov-2 &amp; RSV&amp; ADV &amp; MP Combo Rapid Test Device</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WI-MICR-C86A-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:32:28.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MICR-C85A-25CD</udiDi>
    <basicUdiDi>B-WI-MICR-C85A-25CD</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>FLU A &amp; B &amp; SARS-Cov-2 &amp; RSV&amp; ADV Combo Rapid Test Device</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WI-MICR-C85A-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:32:27.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MICR-C83A-25BP</udiDi>
    <basicUdiDi>B-WI-MICR-C83A-25BP</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>SARS-CoV-2 &amp; Influenza AB Antigen Combo Rapid Test Kit (LFIA)</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WI-MICR-C83A-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:32:23.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MICR-C810C-25U5</udiDi>
    <basicUdiDi>B-WI-MICR-C810C-25U5</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>FLU A/B &amp; SARS-Cov-2 &amp; RSV&amp; ADV &amp;PIV I/III &amp;PIV II &amp;MP &amp; HMV &amp; HRV Combo Rapid Test Device</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WI-MICR-C810C-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:32:22.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MICR-C810C-10TQ</udiDi>
    <basicUdiDi>B-WI-MICR-C810C-10TQ</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>FLU A/B &amp; SARS-Cov-2 &amp; RSV&amp; ADV &amp;PIV I/III &amp;PIV II &amp;MP &amp; HMV &amp; HRV Combo Rapid Test Device</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WI-MICR-C810C-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:32:21.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MICR-C810C-01TP</udiDi>
    <basicUdiDi>B-WI-MICR-C810C-01TP</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>FLU A/B &amp; SARS-Cov-2 &amp; RSV&amp; ADV &amp;PIV I/III &amp;PIV II &amp;MP &amp; HMV &amp; HRV Combo Rapid Test Device</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WI-MICR-C810C-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:32:20.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MICR-C43A-25A3</udiDi>
    <basicUdiDi>B-WI-MICR-C43A-25A3</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>Dengue IgG/IgM and NS1 Rapid Test Device</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WI-MICR-C43A-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:31:01.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-MICR-C43A-109N</udiDi>
    <basicUdiDi>B-WI-MICR-C43A-109N</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>Dengue IgG/IgM and NS1 Rapid Test Device</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WI-MICR-C43A-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:31:01.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-FLU-C82-25HN</udiDi>
    <basicUdiDi>B-WI-FLU-C82-25HN</basicUdiDi>
    <tradeName>Bio-Firm</tradeName>
    <deviceName>Influenza A+B Rapid Test Cassette</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WI-FLU-C82-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:30:59.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-FLU-C82-10H9</udiDi>
    <basicUdiDi>B-WI-FLU-C82-10H9</basicUdiDi>
    <tradeName>Bio-Firm</tradeName>
    <deviceName>Influenza A+B Rapid Test Cassette</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WI-FLU-C82-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:30:55.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WHATOFLU5J</udiDi>
    <basicUdiDi>B-WHATOFLU5J</basicUdiDi>
    <tradeName>D-WHATOFLU5J</tradeName>
    <deviceName>Flu A+B Antigen Rapid Test</deviceName>
    <manufacturerName>W.H.P.M. Bioresearch &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003007</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WH-AT-OFLU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:30:53.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-W73-SH9F</udiDi>
    <basicUdiDi>B-W73-SH9F</basicUdiDi>
    <tradeName>D-W73-SH9F</tradeName>
    <deviceName>One Step Influenza B Test</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W73-SH</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:29:41.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-W73-CH7X</udiDi>
    <basicUdiDi>B-W73-CH7X</basicUdiDi>
    <tradeName>D-W73-CH7X</tradeName>
    <deviceName>One Step Influenza B Test</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W73-CH</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:29:40.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-W72-SH98</udiDi>
    <basicUdiDi>B-W72-SH98</basicUdiDi>
    <tradeName>D-W72-SH98</tradeName>
    <deviceName>One Step Influenza A Test</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W72-SH</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:29:39.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-W72-CH7Q</udiDi>
    <basicUdiDi>B-W72-CH7Q</basicUdiDi>
    <tradeName>D-W72-CH7Q</tradeName>
    <deviceName>One Step Influenza A Test</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W72-CH</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:29:35.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-W71-SH8Z</udiDi>
    <basicUdiDi>B-W71-SH8Z</basicUdiDi>
    <tradeName>D-W71-SH8Z</tradeName>
    <deviceName>One Step Influenza A&amp;B Test</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W71-SH</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:29:34.914Z</lastUpdated>
  </row>
</eudamedExport>