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    <tradeName>Laborant Omicron VariAnt RT-qPCR Kit</tradeName>
    <deviceName>Laborant Omicron VariAnt RT-qPCR Kit</deviceName>
    <manufacturerName>ANT MEDİKAL İTHALAT İHRACAT PAZARLAMA SANAYİ VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000033765</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>OM-RT-DBL-VI-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:07:24.896Z</lastUpdated>
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    <udiDi>08682792797034</udiDi>
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    <tradeName>Laborant SARS-CoV-2 RT-qPCR Kit</tradeName>
    <deviceName>Laborant SARS-CoV-2 RT-qPCR Kit</deviceName>
    <manufacturerName>ANT MEDİKAL İTHALAT İHRACAT PAZARLAMA SANAYİ VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000033765</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CV-RT-DBL-v1-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:07:20.102Z</lastUpdated>
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    <udiDi>06975978080061</udiDi>
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    <tradeName>Anouve</tradeName>
    <deviceName>Whole Blood RNA Extraction Kit</deviceName>
    <manufacturerName>Qingdao Anouve Biological Medical Technology Co. ,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P01BR02-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:28:08.336Z</lastUpdated>
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    <udiDi>06975978080054</udiDi>
    <basicUdiDi>697597808RTA7</basicUdiDi>
    <tradeName>Anouve</tradeName>
    <deviceName>miRNA Extraction Kit (magnetic bead method)</deviceName>
    <manufacturerName>Qingdao Anouve Biological Medical Technology Co. ,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>Artık piyasada değil</deviceStatus>
    <reference>P01RT01-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:28:02.727Z</lastUpdated>
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    <udiDi>06975978080047</udiDi>
    <basicUdiDi>697597808CF7W</basicUdiDi>
    <tradeName>Anouve</tradeName>
    <deviceName>cfDNA Extraction Kit (magnetic bead method)</deviceName>
    <manufacturerName>Qingdao Anouve Biological Medical Technology Co. ,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>Artık piyasada değil</deviceStatus>
    <reference>P01CF01-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:28:02.076Z</lastUpdated>
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    <udiDi>06975532360028</udiDi>
    <basicUdiDi>6975532360028AW</basicUdiDi>
    <tradeName>Cell-Free Fetal DNA Library Prepare Kit</tradeName>
    <deviceName>Cell-Free Fetal DNA Library Prepare Kit</deviceName>
    <manufacturerName>Chengdu Find Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040646</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</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>N002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:15:05.562Z</lastUpdated>
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    <udiDi>06975102440396</udiDi>
    <basicUdiDi>697510244T00R01A7K</basicUdiDi>
    <tradeName>06975102440396</tradeName>
    <deviceName>RT-RAA Nucleic Acid Amplication Kit(Test Strip Method)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>T00R01A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:09:22.670Z</lastUpdated>
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    <udiDi>06975102440389</udiDi>
    <basicUdiDi>697510244T00001AY9</basicUdiDi>
    <tradeName>06975102440389</tradeName>
    <deviceName>RAA Nucleic Acid Amplication Kit(Test Strip Method)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>T00001A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:09:21.869Z</lastUpdated>
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    <udiDi>06975102440372</udiDi>
    <basicUdiDi>697510244F00R01AY2</basicUdiDi>
    <tradeName>06975102440372</tradeName>
    <deviceName>RT-RAA Nucleic Acid Amplication Kit(Fluorescent Method)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>F00R01A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:09:21.063Z</lastUpdated>
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    <udiDi>06975102440365</udiDi>
    <basicUdiDi>697510244F00001AQT</basicUdiDi>
    <tradeName>06975102440365</tradeName>
    <deviceName>RAA Nucleic Acid Amplication Kit(Fluorescent Method)</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>F00001A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:09:17.087Z</lastUpdated>
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    <udiDi>06975102440358</udiDi>
    <basicUdiDi>697510244B00R00AVT</basicUdiDi>
    <tradeName>06975102440358</tradeName>
    <deviceName>RT-RAA Nucleic Acid Amplication Kit</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>B00R00A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:09:16.258Z</lastUpdated>
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    <udiDi>06975102440334</udiDi>
    <basicUdiDi>697510244B00000ANL</basicUdiDi>
    <tradeName>06975102440334</tradeName>
    <deviceName>RAA Nucleic Acid Amplication Kit</deviceName>
    <manufacturerName>Jiangsu Qitian Gene biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000050877</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>B00000A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:09:15.459Z</lastUpdated>
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    <udiDi>04049055001095</udiDi>
    <basicUdiDi>40490550300001068UR</basicUdiDi>
    <tradeName>Reagent Set for DNA•STRIP Kits</tradeName>
    <deviceName>Reagent Set for DNA•STRIP Kits</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>R003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:47:19.366Z</lastUpdated>
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    <udiDi>06970895475259</udiDi>
    <basicUdiDi>B-06970895475259</basicUdiDi>
    <tradeName>06970895475259</tradeName>
    <deviceName>Human Leukocyte Antigen B27 Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M011T024A0C2</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:55:07.698Z</lastUpdated>
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    <udiDi>06933260206445</udiDi>
    <basicUdiDi>B-06933260206445</basicUdiDi>
    <tradeName>SARS-CoV-2 Nucleic Acid eRDA Rapid Qualitative Test Kit（Colloidal gold）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0300504</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:44.683Z</lastUpdated>
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    <udiDi>06933260206438</udiDi>
    <basicUdiDi>B-06933260206438</basicUdiDi>
    <tradeName>SARS-CoV-2 Nucleic Acid eRDA Rapid Qualitative Test Kit（Colloidal gold）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0300503</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:42.297Z</lastUpdated>
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    <udiDi>06933260206421</udiDi>
    <basicUdiDi>B-06933260206421</basicUdiDi>
    <tradeName>SARS-CoV-2 Nucleic Acid eRDA Rapid Qualitative Test Kit（Colloidal gold）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0300502</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:41.089Z</lastUpdated>
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    <tradeName>SARS-CoV-2 Nucleic Acid eRDA Rapid Qualitative Test Kit（Colloidal gold）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0300501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:39.880Z</lastUpdated>
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    <udiDi>09343044003080</udiDi>
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    <tradeName>Low DNA Reagent Cassette</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>40231</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:51.778Z</lastUpdated>
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    <tradeName>Low RNA Reagent Cassette</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>40331</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:51.758Z</lastUpdated>
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