<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>06977597620338</udiDi>
    <basicUdiDi>B-06977597620338</basicUdiDi>
    <tradeName>06977597620338</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 W135）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:38.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620321</udiDi>
    <basicUdiDi>B-06977597620321</basicUdiDi>
    <tradeName>06977597620321</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 Y）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:34.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620314</udiDi>
    <basicUdiDi>B-06977597620314</basicUdiDi>
    <tradeName>06977597620314</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 C）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:33.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620307</udiDi>
    <basicUdiDi>B-06977597620307</basicUdiDi>
    <tradeName>06977597620307</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 A)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:33.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620291</udiDi>
    <basicUdiDi>B-06977597620291</basicUdiDi>
    <tradeName>06977597620291</tradeName>
    <deviceName>Streptococcus Group B 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>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Streptococcus Group B antisera for quality control（Type IX）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:32.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620284</udiDi>
    <basicUdiDi>B-06977597620284</basicUdiDi>
    <tradeName>06977597620284</tradeName>
    <deviceName>Streptococcus Group B 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>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Streptococcus Group B antisera for quality contro（Type VIII）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:28.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620277</udiDi>
    <basicUdiDi>B-06977597620277</basicUdiDi>
    <tradeName>06977597620277</tradeName>
    <deviceName>Streptococcus Group B 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>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Streptococcus Group B antisera for quality control（Type VII）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:27.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977597620260</udiDi>
    <basicUdiDi>B-06977597620260</basicUdiDi>
    <tradeName>06977597620260</tradeName>
    <deviceName>Streptococcus Group B 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>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Streptococcus Group B antisera for quality control（Type VI）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:25.822Z</lastUpdated>
  </row>
</eudamedExport>