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    <basicUdiDi>B-09343044004926</basicUdiDi>
    <tradeName>Viral and Syphilis 12-well</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>87095S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.790Z</lastUpdated>
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    <udiDi>09343044004933</udiDi>
    <basicUdiDi>B-09343044004933</basicUdiDi>
    <tradeName>Step 2 Plates for Urinogenital and Resistance 12-well</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>87123P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.772Z</lastUpdated>
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    <udiDi>09343044004940</udiDi>
    <basicUdiDi>B-09343044004940</basicUdiDi>
    <tradeName>Step 1 tubes for Urinogenital and Resistance 12-well</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>87123S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.750Z</lastUpdated>
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    <udiDi>09343044005275</udiDi>
    <basicUdiDi>93430440W010590010259</basicUdiDi>
    <tradeName>RIDA®Plex L DNA Reservoir</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40611</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.728Z</lastUpdated>
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    <udiDi>09343044005282</udiDi>
    <basicUdiDi>93430440W010590010259</basicUdiDi>
    <tradeName>RIDA®Plex L RNA Reservoir</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40711</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.701Z</lastUpdated>
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    <udiDi>09343044005299</udiDi>
    <basicUdiDi>93430440W010590010259</basicUdiDi>
    <tradeName>RIDA®Plex M DNA Reservoir</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40621</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.676Z</lastUpdated>
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    <udiDi>09343044005305</udiDi>
    <basicUdiDi>93430440W010590010259</basicUdiDi>
    <tradeName>RIDA®Plex M RNA Reservoir</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40721</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.652Z</lastUpdated>
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    <udiDi>09343044005312</udiDi>
    <basicUdiDi>93430440W010590010259</basicUdiDi>
    <tradeName>RIDA®Plex S DNA Reservoir</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40631</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.628Z</lastUpdated>
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    <udiDi>09343044005329</udiDi>
    <basicUdiDi>93430440W010590010259</basicUdiDi>
    <tradeName>RIDA®Plex S RNA Reservoir</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40731</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.607Z</lastUpdated>
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    <udiDi>09343044005404</udiDi>
    <basicUdiDi>B-09343044005404</basicUdiDi>
    <tradeName>Synthetic Positive Controls for Respiratory Pathogens</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.586Z</lastUpdated>
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    <udiDi>09343044005411</udiDi>
    <basicUdiDi>93430440W02039006V6</basicUdiDi>
    <tradeName>RIDA®Jump System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039006</emdnCode>
    <emdnDescription>DNA THERMAL CYCLERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96221</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.567Z</lastUpdated>
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    <udiDi>09343044005510</udiDi>
    <basicUdiDi>93430440W010590010157</basicUdiDi>
    <tradeName>Puryx Comprehensive DNA / RNA Extraction Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93610</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.546Z</lastUpdated>
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    <udiDi>09343044005831</udiDi>
    <basicUdiDi>93430440W02039006V6</basicUdiDi>
    <tradeName>HighPlex Ascend System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039006</emdnCode>
    <emdnDescription>DNA THERMAL CYCLERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.335Z</lastUpdated>
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    <udiDi>09343044005848</udiDi>
    <basicUdiDi>93430440W02039006V6</basicUdiDi>
    <tradeName>RIDA®Xplore System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039006</emdnCode>
    <emdnDescription>DNA THERMAL CYCLERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96521</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.307Z</lastUpdated>
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    <udiDi>09343044006166</udiDi>
    <basicUdiDi>93430440W02050106U2</basicUdiDi>
    <tradeName>RIDA®Xtract 24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96420</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.150Z</lastUpdated>
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    <udiDi>09343044006203</udiDi>
    <basicUdiDi>93430440W010590010157</basicUdiDi>
    <tradeName>RIDA®Xtract 24 Blood DNA Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93031</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.113Z</lastUpdated>
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    <udiDi>09343044006210</udiDi>
    <basicUdiDi>93430440W010590010157</basicUdiDi>
    <tradeName>RIDA®Xtract 24 Pathogen Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.094Z</lastUpdated>
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    <udiDi>09343044006227</udiDi>
    <basicUdiDi>B-09343044006227</basicUdiDi>
    <tradeName>Synthetic Positive Controls for STIs and Herpes</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91021</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.075Z</lastUpdated>
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    <udiDi>09343044006357</udiDi>
    <basicUdiDi>B-09343044006357</basicUdiDi>
    <tradeName>RIDA®Plex Parasites 8 well Step 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>85021P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.031Z</lastUpdated>
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    <udiDi>09343044006364</udiDi>
    <basicUdiDi>B-09343044006364</basicUdiDi>
    <tradeName>RIDA®Plex Parasites 8 well Step 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>85021S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.008Z</lastUpdated>
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