<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08431673700331</udiDi>
    <basicUdiDi>B-08431673700331</basicUdiDi>
    <tradeName>Anti-E monoclonal</tradeName>
    <deviceName>Blood grouping</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030202</emdnCode>
    <emdnDescription>RHESUS PHENOTYPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1700033</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:30:18.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673700317</udiDi>
    <basicUdiDi>B-08431673700317</basicUdiDi>
    <tradeName>Anti-C monoclonal</tradeName>
    <deviceName>Blood grouping</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030202</emdnCode>
    <emdnDescription>RHESUS PHENOTYPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1700031</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:30:17.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673700249</udiDi>
    <basicUdiDi>B-08431673700249</basicUdiDi>
    <tradeName>Anti-C+D+E  monoclonal</tradeName>
    <deviceName>Blood grouping</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030202</emdnCode>
    <emdnDescription>RHESUS PHENOTYPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1700024</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:30:16.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673700218</udiDi>
    <basicUdiDi>B-08431673700218</basicUdiDi>
    <tradeName>Anti-D IgG + IgM Monoclonal</tradeName>
    <deviceName>Blood grouping</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030201</emdnCode>
    <emdnDescription>RHESUS D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1700021</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:30:16.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673700065</udiDi>
    <basicUdiDi>B-08431673700065</basicUdiDi>
    <tradeName>Anti-A,B Monoclonal</tradeName>
    <deviceName>Blood grouping</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030102</emdnCode>
    <emdnDescription>ABO SERA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1700006</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:30:12.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673700027</udiDi>
    <basicUdiDi>B-08431673700027</basicUdiDi>
    <tradeName>Anti-A Monoclonal</tradeName>
    <deviceName>Blood grouping</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030102</emdnCode>
    <emdnDescription>ABO SERA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1700002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:30:11.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640137341145</udiDi>
    <basicUdiDi>B-07640137341145</basicUdiDi>
    <tradeName>Neutr-AB II</tradeName>
    <deviceName>Neutr-AB II</deviceName>
    <manufacturerName>Medion Grifols Diagnostics AG</manufacturerName>
    <manufacturerSrn>CH-MF-000024272</manufacturerSrn>
    <authorisedRepresentativeName>Diagnostic Grifols, S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001573</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213424</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:41:28.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640137340957</udiDi>
    <basicUdiDi>B-07640137340957</basicUdiDi>
    <tradeName>Anti-Lua</tradeName>
    <deviceName>Anti-Lua</deviceName>
    <manufacturerName>Medion Grifols Diagnostics AG</manufacturerName>
    <manufacturerSrn>CH-MF-000024272</manufacturerSrn>
    <authorisedRepresentativeName>Diagnostic Grifols, S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001573</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213553</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:41:24.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350123504545</udiDi>
    <basicUdiDi>B-07350123504545</basicUdiDi>
    <tradeName>Vitamin D Rapid Test Cassette</tradeName>
    <deviceName>Vitamin D Rapid Test Cassette</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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030901</emdnCode>
    <emdnDescription>COMBINED ABO TYPING + RHESUS D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OVD-402H</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:17:27.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978168790122</udiDi>
    <basicUdiDi>B-06978168790122</basicUdiDi>
    <tradeName>06978168790122</tradeName>
    <deviceName>LH Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:58.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978168790108</udiDi>
    <basicUdiDi>B-06978168790108</basicUdiDi>
    <tradeName>06978168790108</tradeName>
    <deviceName>HCG Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Strip</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:57.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978168790092</udiDi>
    <basicUdiDi>B-06978168790092</basicUdiDi>
    <tradeName>06978168790092</tradeName>
    <deviceName>HCG Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:56.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978168790115</udiDi>
    <basicUdiDi>B-06978168790115</basicUdiDi>
    <tradeName>06978168790115</tradeName>
    <deviceName>LH Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Strip</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:55.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978168790085</udiDi>
    <basicUdiDi>B-06978168790085</basicUdiDi>
    <tradeName>06978168790085</tradeName>
    <deviceName>HCG Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Midstream</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:52.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978168790078</udiDi>
    <basicUdiDi>B-06978168790078</basicUdiDi>
    <tradeName>06978168790078</tradeName>
    <deviceName>Dengue IgG/IgM Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Strip</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:37.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978168790061</udiDi>
    <basicUdiDi>B-06978168790061</basicUdiDi>
    <tradeName>06978168790061</tradeName>
    <deviceName>Dengue IgG/IgM Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:36.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978168790054</udiDi>
    <basicUdiDi>B-06978168790054</basicUdiDi>
    <tradeName>06978168790054</tradeName>
    <deviceName>Dengue IgG/IgM Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Midstream</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:35.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978168790047</udiDi>
    <basicUdiDi>B-06978168790047</basicUdiDi>
    <tradeName>06978168790047</tradeName>
    <deviceName>Malaria Pf/Pv Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:34.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978168790030</udiDi>
    <basicUdiDi>B-06978168790030</basicUdiDi>
    <tradeName>06978168790030</tradeName>
    <deviceName>TP Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:30.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978168790023</udiDi>
    <basicUdiDi>B-06978168790023</basicUdiDi>
    <tradeName>06978168790023</tradeName>
    <deviceName>TP Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Strip</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:30.001Z</lastUpdated>
  </row>
</eudamedExport>