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<eudamedExport entity="devices">
  <row>
    <udiDi>D-IHAGM-4255D</udiDi>
    <basicUdiDi>B-IHAGM-4255D</basicUdiDi>
    <tradeName>HAV IgG/IgM Combo Rapid Test  Cassette</tradeName>
    <deviceName>HAV IgG/IgM Combo 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHA-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:47:35.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHA-402MD</udiDi>
    <basicUdiDi>B-IHA-402MD</basicUdiDi>
    <tradeName>HAV IgM Rapid Test Cassette</tradeName>
    <deviceName>HAV IgM 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHA-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:47:34.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056771103916</udiDi>
    <basicUdiDi>805677131128047</basicUdiDi>
    <tradeName>LIAISON® MUREX Anti-HEV IgM</tradeName>
    <deviceName>LIAISON® MUREX Anti-HEV IgM</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311280</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:45.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056771103879</udiDi>
    <basicUdiDi>805677131127044</basicUdiDi>
    <tradeName>LIAISON® MUREX Anti-HEV IgG</tradeName>
    <deviceName>LIAISON® MUREX Anti-HEV IgG</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEV ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311270</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:41.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056771100151</udiDi>
    <basicUdiDi>80567713101703Q</basicUdiDi>
    <tradeName>LIAISON® Anti-HAV</tradeName>
    <deviceName>LIAISON® Anti-HAV</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310170</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:10.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414481876</udiDi>
    <basicUdiDi>0405686900748W2</basicUdiDi>
    <tradeName>ADVIA Centaur aHAVT assay</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_KIT_aHAVT</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10322676</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:36.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840312096</udiDi>
    <basicUdiDi>B-69743840312096</basicUdiDi>
    <tradeName>HAV IGG IGM Rapid Test</tradeName>
    <deviceName>HAV IGG IGM 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>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3023101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:53.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6971771200989A5</udiDi>
    <basicUdiDi>B-6971771200989A5</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>HAV Rapid Test</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAV-W21-GM</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:57:25.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757990612QC</udiDi>
    <basicUdiDi>B-693757990612QC</basicUdiDi>
    <tradeName>Diagnostic kit for anti-HAV IgM( Colloidal Gold)</tradeName>
    <deviceName>Diagnostic kit for anti-HAV IgM( Colloidal Gold)</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>HAV-IgM 501201 HAV-IgM 251202</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:48:59.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940006433</udiDi>
    <basicUdiDi>B-07332940006433</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® HCV VL Fingerstick</deviceName>
    <manufacturerName>Cepheid AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020307</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXHCV-FS-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:55:57.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940002480</udiDi>
    <basicUdiDi>B-07332940002480</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® HBV Viral Load</deviceName>
    <manufacturerName>Cepheid AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020216</emdnCode>
    <emdnDescription>HEPATITIS B VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXHBV-VL-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:55:54.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940001544</udiDi>
    <basicUdiDi>B-07332940001544</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® HCV Viral Load</deviceName>
    <manufacturerName>Cepheid AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020307</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXHCV-VL-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:55:17.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974785750594</udiDi>
    <basicUdiDi>B-06974785750594</basicUdiDi>
    <tradeName>HAV Rapid Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>HAV Rapid Test Cassette (Serum/Plasma)</deviceName>
    <manufacturerName>Anhui Formaster Biosci Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002305</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHA-6013</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:55.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIHEVM078009</udiDi>
    <basicUdiDi>B-+ENTIHEVM078009</basicUdiDi>
    <tradeName>+ENTIHEVM078009</tradeName>
    <deviceName>NovaLisa® Hepatitis E Virus (HEV) IgM</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEVM0780</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:14:15.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIHEVG078003</udiDi>
    <basicUdiDi>B-+ENTIHEVG078003</basicUdiDi>
    <tradeName>+ENTIHEVG078003</tradeName>
    <deviceName>NovaLisa® Hepatitis E Virus (HEV) IgG</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEV ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEVG0780</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:14:13.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905459006929</udiDi>
    <basicUdiDi>8905459MHBSAGRTG4</basicUdiDi>
    <tradeName>08905459006929</tradeName>
    <deviceName>MERISCREEN HBsAg</deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020201</emdnCode>
    <emdnDescription>HEPATITIS B SURFACE ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RPDHBV-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:52:36.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905459006912</udiDi>
    <basicUdiDi>8905459MHCVRT9A</basicUdiDi>
    <tradeName>08905459006912</tradeName>
    <deviceName>MERISCREEN HCV</deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020308</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS (HCV) ANTIGEN/ANTIBODY COMBO TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RPDHCV-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:52:35.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M521071045</udiDi>
    <basicUdiDi>B-++M521071045</basicUdiDi>
    <tradeName>EIAgen HBsAg Kit</tradeName>
    <deviceName>EIAgen HBsAg  Kit</deviceName>
    <manufacturerName>ADALTIS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000028990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020201</emdnCode>
    <emdnDescription>HEPATITIS B SURFACE ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>071011 / 071012 / 071015</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:48:29.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680018942039</udiDi>
    <basicUdiDi>868001894PCRHPTHBVQT100D9</basicUdiDi>
    <tradeName>Anatolia Geneworks</tradeName>
    <deviceName>Bosphore HBV Quantification Kit</deviceName>
    <manufacturerName>Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000022487</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020216</emdnCode>
    <emdnDescription>HEPATITIS B VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABHBQ1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:33:15.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436610290043</udiDi>
    <basicUdiDi>843661029RTPCR017018R</basicUdiDi>
    <tradeName>HEPATITIS DELTA REALTIME PCR KIT</tradeName>
    <deviceName>HEPATITIS DELTA REALTIME PCR KIT</deviceName>
    <manufacturerName>Vircell, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000004099</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020406</emdnCode>
    <emdnDescription>HEPATITIS DELTA VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTPCR017-LP</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:22:37.229Z</lastUpdated>
  </row>
</eudamedExport>