<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09343044005701</udiDi>
    <basicUdiDi>B-09343044005701</basicUdiDi>
    <tradeName>Step 1 tubes for Enteric Viruses 8-well</tradeName>
    <deviceName>Step 1 tubes for Enteric Viruses 8-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>85037S</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:43:51.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044005671</udiDi>
    <basicUdiDi>B-09343044005671</basicUdiDi>
    <tradeName>Step 2 Plates for Faecal Bacteria and Parasites 12-well</tradeName>
    <deviceName>Step 2 Plates for Faecal Bacteria and Parasites 12-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>85041P</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:43:47.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044005664</udiDi>
    <basicUdiDi>B-09343044005664</basicUdiDi>
    <tradeName>Step 1 tubes for Faecal Bacteria and Parasites 12-well</tradeName>
    <deviceName>Step 1 tubes for Faecal Bacteria and Parasites 12-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>85041S</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:43:46.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044004940</udiDi>
    <basicUdiDi>B-09343044004940</basicUdiDi>
    <tradeName>Step 1 tubes for Urinogenital and Resistance 12-well</tradeName>
    <deviceName>Step 1 tubes for Urinogenital and Resistance 12-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</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>87123S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:43:27.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044004933</udiDi>
    <basicUdiDi>B-09343044004933</basicUdiDi>
    <tradeName>Step 2 Plates for Urinogenital and Resistance 12-well</tradeName>
    <deviceName>Step 2 Plates for Urinogenital and Resistance 12-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</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>87123P</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:43:26.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044004186</udiDi>
    <basicUdiDi>B-09343044004186</basicUdiDi>
    <tradeName>Respiratory Pathogens 16-well</tradeName>
    <deviceName>Step 1 tubes for Respiratory Pathogens 16-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20620S</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:43:19.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044004179</udiDi>
    <basicUdiDi>B-09343044004179</basicUdiDi>
    <tradeName>Respiratory Pathogens 16-well</tradeName>
    <deviceName>Step 2 Plates for Respiratory Pathogens 16-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20620P</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:43:15.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044003615</udiDi>
    <basicUdiDi>B-09343044003615</basicUdiDi>
    <tradeName>Step 1 tubes for Respiratory Pathogens 24-well</tradeName>
    <deviceName>Respiratory Pathogens 24-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80617S</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:43:08.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044003608</udiDi>
    <basicUdiDi>B-09343044003608</basicUdiDi>
    <tradeName>Step 2 Plates for Respiratory Pathogens 24-well</tradeName>
    <deviceName>Respiratory Pathogens 24-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80617P</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:43:07.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044003509</udiDi>
    <basicUdiDi>B-09343044003509</basicUdiDi>
    <tradeName>Respiratory Pathogens 12-well</tradeName>
    <deviceName>Respiratory Pathogens 12-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80618P</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:43:06.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044003493</udiDi>
    <basicUdiDi>B-09343044003493</basicUdiDi>
    <tradeName>Respiratory Pathogens 12-well</tradeName>
    <deviceName>Respiratory Pathogens 12-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80618S</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:43:02.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044002861</udiDi>
    <basicUdiDi>B-09343044002861</basicUdiDi>
    <tradeName>Step 1 tubes for Urinogenital and Resistance 12 well</tradeName>
    <deviceName>Step 1 tubes for Urinogenital and Resistance 12 well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</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>27123S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:42:59.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044002854</udiDi>
    <basicUdiDi>B-09343044002854</basicUdiDi>
    <tradeName>Step 2 Plates for Urinogenital and Resistance 12 well</tradeName>
    <deviceName>Step 2 Plates for Urinogenital and Resistance 12 well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</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>27123P</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:42:55.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044002762</udiDi>
    <basicUdiDi>B-09343044002762</basicUdiDi>
    <tradeName>SARS-CoV-2, Influenza and RSV 8-well</tradeName>
    <deviceName>Step 1 tubes for SARS-CoV-2, Influenza and RSV 8-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80081S</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:42:55.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044002755</udiDi>
    <basicUdiDi>B-09343044002755</basicUdiDi>
    <tradeName>SARS-CoV-2, Influenza and RSV 8-well</tradeName>
    <deviceName>Step 2 Plates for SARS-CoV-2, Influenza and RSV 8-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80081P</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:42:54.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044002229</udiDi>
    <basicUdiDi>B-09343044002229</basicUdiDi>
    <tradeName>Step 1 tubes for Urinogenital (8-well)</tradeName>
    <deviceName>Step 1 tubes for Urinogenital (8-well)</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</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>27113S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:42:22.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044002212</udiDi>
    <basicUdiDi>B-09343044002212</basicUdiDi>
    <tradeName>Step 2 Plates for Urinogenital (8-well)</tradeName>
    <deviceName>Step 2 Plates for Urinogenital (8-well)</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</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>27113P</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:42:21.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044002120</udiDi>
    <basicUdiDi>B-09343044002120</basicUdiDi>
    <tradeName>Step 1 tubes for STI (16-well)</tradeName>
    <deviceName>Step 1 tubes for STI (16-well)</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</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>27112S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:42:16.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044002113</udiDi>
    <basicUdiDi>B-09343044002113</basicUdiDi>
    <tradeName>Step 2 Plates for STI (16-well)</tradeName>
    <deviceName>Step 2 Plates for STI (16-well)</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</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>27112P</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:42:15.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>09343044002038</udiDi>
    <basicUdiDi>B-09343044002038</basicUdiDi>
    <tradeName>Staphylococcus + VRE 8-well</tradeName>
    <deviceName>Step 1 tubes for Staphylococcus + VRE 8-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21340S</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:42:09.116Z</lastUpdated>
  </row>
</eudamedExport>