<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04050598007994</udiDi>
    <basicUdiDi>B-04050598007994</basicUdiDi>
    <tradeName>MutaPlex® RespiraScreen 2 DIFF, PCR</tradeName>
    <deviceName>MutaPlex® RespiraScreen 2 DIFF, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG192896</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:46.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598006249</udiDi>
    <basicUdiDi>B-04050598006249</basicUdiDi>
    <tradeName>MutaPlex® RespiraScreen 1, PCR</tradeName>
    <deviceName>MutaPlex® RespiraScreen 1, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1927-384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:24.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598006232</udiDi>
    <basicUdiDi>B-04050598006232</basicUdiDi>
    <tradeName>MutaPlex® RespiraScreen 1, PCR</tradeName>
    <deviceName>MutaPlex® RespiraScreen 1, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG192796</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:46:20.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598005242</udiDi>
    <basicUdiDi>B-04050598005242</basicUdiDi>
    <tradeName>MutaPLEX® GastroSys4</tradeName>
    <deviceName>MutaPLEX® GastroSys4</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1920-96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:43:49.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598005259</udiDi>
    <basicUdiDi>B-04050598005259</basicUdiDi>
    <tradeName>MutaPLEX® GastroSys4</tradeName>
    <deviceName>MutaPLEX® GastroSys 4</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1920-384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:43:48.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598003071</udiDi>
    <basicUdiDi>B-04050598003071</basicUdiDi>
    <tradeName>MutaPLEX® RespiraSys 1, PCR</tradeName>
    <deviceName>MutaPLEX® RespiraSys 1, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG198432</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:42:28.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598003019</udiDi>
    <basicUdiDi>B-04050598003019</basicUdiDi>
    <tradeName>MutaPLEX® GastroSys 3 (Multiplex-Panel), RT-PCR</tradeName>
    <deviceName>MutaPLEX® GastroSys 3 (Multiplex-Panel), RT-PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG198832</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:42:20.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002715</udiDi>
    <basicUdiDi>B-04050598002715</basicUdiDi>
    <tradeName>MutaPLEX® GastroSys 1 (Multiplex-Panel), RT-PCR</tradeName>
    <deviceName>MutaPLEX® GastroSys 1 (Multiplex-Panel), RT-PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG198632</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:42:03.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002517</udiDi>
    <basicUdiDi>B-04050598002517</basicUdiDi>
    <tradeName>MutaPLEX® RespiraSys 1, PCR</tradeName>
    <deviceName>MutaPLEX® RespiraSys 1, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG198496</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:47.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002456</udiDi>
    <basicUdiDi>B-04050598002456</basicUdiDi>
    <tradeName>MutaPLEX® GastroSys 3 (Multiplex-Panel), RT-PCR</tradeName>
    <deviceName>MutaPLEX® GastroSys 3 (Multiplex-Panel), RT-PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG198896</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:24.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002432</udiDi>
    <basicUdiDi>B-04050598002432</basicUdiDi>
    <tradeName>MutaPLEX® GastroSys 1 (Multiplex-Panel), RT-PCR</tradeName>
    <deviceName>MutaPLEX® GastroSys1 Mulitplex-Test: Adenovirus, Norovirus (GI &amp; II), Rotavirus, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG198696</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:23.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598002234</udiDi>
    <basicUdiDi>B-04050598002234</basicUdiDi>
    <tradeName>MutaPLEX® Tropica 1, PCR</tradeName>
    <deviceName>MutaPLEX® Tropica 1, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG199096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:05.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095160479</udiDi>
    <basicUdiDi>B-04049095160479</basicUdiDi>
    <tradeName>04049095160479</tradeName>
    <deviceName>RIDA®GENE Bacterial Stool Panel I</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PG2415</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:06:25.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095160233</udiDi>
    <basicUdiDi>B-04049095160233</basicUdiDi>
    <tradeName>04049095160233</tradeName>
    <deviceName>RIDA®GENE Bacterial Stool Panel</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PG2405</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:06:18.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055003679</udiDi>
    <basicUdiDi>B-04049055003679</basicUdiDi>
    <tradeName>FluoroType® STI VER 1.0</tradeName>
    <deviceName>FluoroType® STI VER 1.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070501</emdnCode>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1877362</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:04:20.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-000012807193070QQ</udiDi>
    <basicUdiDi>B-000012807193070QQ</basicUdiDi>
    <tradeName>14 Kinds of Respiratory Pathogens Combined Nucleic Acid Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>14 Kinds of Respiratory Pathogens Combined Nucleic Acid Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT159</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:59:50.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-00001280718806BSF</udiDi>
    <basicUdiDi>B-00001280718806BSF</basicUdiDi>
    <tradeName>4 Kinds of Respiratory Viruses Nucleic Acid Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>4 Kinds of Respiratory Viruses Nucleic Acid Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT099</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:59:43.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-000012807174097QV</udiDi>
    <basicUdiDi>B-000012807174097QV</basicUdiDi>
    <tradeName>14 Kinds of Genitourinary Tract Infection Pathogen Nucleic Acid Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>14 Kinds of Genitourinary Tract Infection Pathogen Nucleic Acid Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070501</emdnCode>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-UR040</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:59:18.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0000128071590BASL</udiDi>
    <basicUdiDi>B-0000128071590BASL</basicUdiDi>
    <tradeName>SARS-CoV-2, Respiratory Syncytium, and Influenza A&amp;B Antigen Combined Detection Kit(Latex Method)</tradeName>
    <deviceName>SARS-CoV-2, Respiratory Syncytium, and Influenza A&amp;B Antigen Combined Detection Kit(Latex Method)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT152</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:58:41.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>09352224000078</udiDi>
    <basicUdiDi>9352224011210WD</basicUdiDi>
    <tradeName>PlexPCR VHS (550)</tradeName>
    <deviceName>PlexPCR VHS</deviceName>
    <manufacturerName>SpeeDx Pty. Ltd.</manufacturerName>
    <manufacturerSrn>AU-MF-000016649</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070501</emdnCode>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1123001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:07:09.566Z</lastUpdated>
  </row>
</eudamedExport>