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    <tradeName>Medium DNA Reagent Reservoir (4 pack)</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>40421</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:51.549Z</lastUpdated>
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    <udiDi>09343044003660</udiDi>
    <basicUdiDi>93430440W010590010259</basicUdiDi>
    <tradeName>Low DNA Reagent Reservoir (4 pack)</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>40431</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:51.527Z</lastUpdated>
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    <udiDi>09343044003684</udiDi>
    <basicUdiDi>93430440W010590010259</basicUdiDi>
    <tradeName>Medium RNA Reagent Reservoir (4 pack)</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>40521</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:51.506Z</lastUpdated>
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    <udiDi>09343044003691</udiDi>
    <basicUdiDi>93430440W010590010259</basicUdiDi>
    <tradeName>Low RNA Reagent Reservoir (4 pack)</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>40531</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:51.486Z</lastUpdated>
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    <udiDi>09343044003837</udiDi>
    <basicUdiDi>B-09343044003837</basicUdiDi>
    <tradeName>Synthetic Positive Controls for HPV</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91191</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:51.467Z</lastUpdated>
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    <udiDi>09343044003899</udiDi>
    <basicUdiDi>B-09343044003899</basicUdiDi>
    <tradeName>Vaginitis and vaginosis 12-well</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>87124P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:51.447Z</lastUpdated>
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    <udiDi>09343044003905</udiDi>
    <basicUdiDi>B-09343044003905</basicUdiDi>
    <tradeName>Vaginitis and vaginosis 12-well</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>87124S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:51.426Z</lastUpdated>
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    <udiDi>09343044004179</udiDi>
    <basicUdiDi>B-09343044004179</basicUdiDi>
    <tradeName>Respiratory Pathogens 16-well</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20620P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:51.408Z</lastUpdated>
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    <udiDi>09343044004186</udiDi>
    <basicUdiDi>B-09343044004186</basicUdiDi>
    <tradeName>Respiratory Pathogens 16-well</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20620S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:51.391Z</lastUpdated>
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    <udiDi>09343044004292</udiDi>
    <basicUdiDi>93430440W010590010157</basicUdiDi>
    <tradeName>MT-Prep Blood DNA Extraction kit 1200 (48 samples)</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>2026-06-21T14:34:51.375Z</lastUpdated>
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    <udiDi>09343044004339</udiDi>
    <basicUdiDi>93430440W02050106U2</basicUdiDi>
    <tradeName>MT-Prep XL 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>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:51.360Z</lastUpdated>
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    <udiDi>09343044004490</udiDi>
    <basicUdiDi>93430440W02039006V6</basicUdiDi>
    <tradeName>UltraPlex 3 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>94601</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:51.345Z</lastUpdated>
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    <udiDi>09343044004735</udiDi>
    <basicUdiDi>B-09343044004735</basicUdiDi>
    <tradeName>CRE Reference 24-well</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81099P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:51.324Z</lastUpdated>
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    <udiDi>09343044004742</udiDi>
    <basicUdiDi>B-09343044004742</basicUdiDi>
    <tradeName>CRE Reference 24-well</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81099S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:51.299Z</lastUpdated>
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    <udiDi>09343044004780</udiDi>
    <basicUdiDi>93430440W010590010157</basicUdiDi>
    <tradeName>RIDA®PrepX Stool 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>90240</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.828Z</lastUpdated>
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    <udiDi>09343044004919</udiDi>
    <basicUdiDi>B-09343044004919</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>87095P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:36.808Z</lastUpdated>
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    <udiDi>09343044004926</udiDi>
    <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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