<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08053172971540</udiDi>
    <basicUdiDi>B-08053172971540</basicUdiDi>
    <tradeName>Rosa Bengala</tradeName>
    <deviceName>Rosa Bengala/Bengal Rose</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7802</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:46:38.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172970338</udiDi>
    <basicUdiDi>B-08053172970338</basicUdiDi>
    <tradeName>Rosa Bengala</tradeName>
    <deviceName>Rosa Bengala/Bengal Rose</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7802/50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:42:25.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698402017</udiDi>
    <basicUdiDi>B-06977698402017</basicUdiDi>
    <tradeName>Typhoid IgG/lgM Antibody Rapid Test Cassette (Colloidal Gold)</tradeName>
    <deviceName>Typhoid IgG/lgM Antibody Rapid Test Cassette (Colloidal Gold)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD037</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:28:25.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620505</udiDi>
    <basicUdiDi>B-06977597620505</basicUdiDi>
    <tradeName>06977597620505</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis antisera for quality control（Group Z）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:27:06.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620499</udiDi>
    <basicUdiDi>B-06977597620499</basicUdiDi>
    <tradeName>06977597620499</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis antisera for quality control（Group X）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:27:05.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620482</udiDi>
    <basicUdiDi>B-06977597620482</basicUdiDi>
    <tradeName>06977597620482</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis antisera for quality control（Group D）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:27:01.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620475</udiDi>
    <basicUdiDi>B-06977597620475</basicUdiDi>
    <tradeName>06977597620475</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis antisera for quality control（Group W135）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:27:01.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620468</udiDi>
    <basicUdiDi>B-06977597620468</basicUdiDi>
    <tradeName>06977597620468</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis antisera for quality control(Group Y)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:27:00.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620451</udiDi>
    <basicUdiDi>B-06977597620451</basicUdiDi>
    <tradeName>06977597620451</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis antisera for quality control(Group C)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:59.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620444</udiDi>
    <basicUdiDi>B-06977597620444</basicUdiDi>
    <tradeName>06977597620444</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis antisera for quality control (Group A)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:54.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620437</udiDi>
    <basicUdiDi>B-06977597620437</basicUdiDi>
    <tradeName>06977597620437</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis latex antisera（Group Z）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:53.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620420</udiDi>
    <basicUdiDi>B-06977597620420</basicUdiDi>
    <tradeName>06977597620420</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis latex antisera（Group X）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:53.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620413</udiDi>
    <basicUdiDi>B-06977597620413</basicUdiDi>
    <tradeName>06977597620413</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis latex antisera（Group D）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:52.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620406</udiDi>
    <basicUdiDi>B-06977597620406</basicUdiDi>
    <tradeName>06977597620406</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis latex antisera（Group W135）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:48.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620390</udiDi>
    <basicUdiDi>B-06977597620390</basicUdiDi>
    <tradeName>06977597620390</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis latex antisera（Group Y）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:47.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620383</udiDi>
    <basicUdiDi>B-06977597620383</basicUdiDi>
    <tradeName>06977597620383</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis latex antisera（Group C）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:46.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620376</udiDi>
    <basicUdiDi>B-06977597620376</basicUdiDi>
    <tradeName>06977597620376</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis latex antisera (Group A)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:45.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620369</udiDi>
    <basicUdiDi>B-06977597620369</basicUdiDi>
    <tradeName>06977597620369</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis Group antisera（Group Z）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:41.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620352</udiDi>
    <basicUdiDi>B-06977597620352</basicUdiDi>
    <tradeName>06977597620352</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis Group antisera（Group X）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:40.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620345</udiDi>
    <basicUdiDi>B-06977597620345</basicUdiDi>
    <tradeName>06977597620345</tradeName>
    <deviceName>Neisseria meningitidis antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011711</emdnCode>
    <emdnDescription>NEISSERIA MENINGITIDIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neisseria meningitidis Group antisera（Group D）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:39.432Z</lastUpdated>
  </row>
</eudamedExport>