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    <deviceName>ONEblot Near-Field Chemi lmager</deviceName>
    <manufacturerName>Aperbio  Technologies  (Suzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000045149</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <deviceName>Aegaeon Digital PCR System</deviceName>
    <manufacturerName>Aperbio  Technologies  (Suzhou) Co., Ltd</manufacturerName>
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    <deviceName>Fully Automated Nucleic Acid Extractor</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
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    <udiDi>06973609151128</udiDi>
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    <deviceName>Fully Automated Nucleic Acid Extractor</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>（01）6973609151128（11）200815（21）5B22020189</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:29.640Z</lastUpdated>
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    <udiDi>06973609151111</udiDi>
    <basicUdiDi>697360915111KG</basicUdiDi>
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    <deviceName>Fully Automated Nucleic Acid Extractor</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>（01）6973609151111（11）210106（21）5B12021001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:28.858Z</lastUpdated>
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    <udiDi>06973609150565</udiDi>
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    <deviceName>Fully Automated Nucleic Acid Extractor</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>（01）6973609150565（11）210103（21）5562021001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:17.630Z</lastUpdated>
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    <deviceName>Fully Automated Nucleic Acid Extractor</deviceName>
    <manufacturerName>Yantai Addcare Bio-Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018409</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>（01）6973609150183（11）210105（21）5B92021001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:49:11.232Z</lastUpdated>
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    <udiDi>06973368211255</udiDi>
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    <tradeName>Full Automatic Nucleic Acid Extractor</tradeName>
    <deviceName>Full Automatic Nucleic Acid Extractor</deviceName>
    <manufacturerName>Shenzhen Huisong Technology Development Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000032903</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9008</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:32:06.453Z</lastUpdated>
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    <udiDi>06973342000257</udiDi>
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    <tradeName>Real-time PCR System</tradeName>
    <deviceName>Real-time PCR System</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STC-96A PLUS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:30:50.311Z</lastUpdated>
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    <udiDi>06438147376209</udiDi>
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    <tradeName>chemagic Prime Jr-D</tradeName>
    <deviceName>chemagic Prime Jr-D</deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2029-0010</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:04:15.880Z</lastUpdated>
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    <udiDi>06438147356706</udiDi>
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    <tradeName>chemagic 360-D</tradeName>
    <deviceName>chemagic 360-D</deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2024-0010</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:04:04.682Z</lastUpdated>
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    <udiDi>06438147332205</udiDi>
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    <tradeName>chemagic Prepito-D</tradeName>
    <deviceName>chemagic Prepito-D</deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2022-0020</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:04:00.677Z</lastUpdated>
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    <udiDi>05060536830231</udiDi>
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    <tradeName>DNA Fragmentation Quantification Assay</tradeName>
    <deviceName>DNA Fragmentation Quantification Assay</deviceName>
    <manufacturerName>EntroGen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022721</manufacturerSrn>
    <authorisedRepresentativeName>TANJA TOPOVSEK S.P.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000022518</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FQA-RT40</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:23:05.877Z</lastUpdated>
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    <udiDi>05056793800001</udiDi>
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    <tradeName>GridION Sequencing Device Dx1 RGL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Oxford Nanopore Diagnostics Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000046755</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>OND-GRD-DX1-RGL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:01:28.771Z</lastUpdated>
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    <udiDi>04262367270007</udiDi>
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    <tradeName>04262367270007</tradeName>
    <deviceName>LabDisk-Analyzer</deviceName>
    <manufacturerName>Dermagnostix GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025137</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESDR12-MB-1000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:27:52.561Z</lastUpdated>
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    <udiDi>04053228048015</udiDi>
    <basicUdiDi>4053228ICARELUM0000000128</basicUdiDi>
    <tradeName>careHPV Test Luminometer</tradeName>
    <deviceName>careHPV Test Luminometer</deviceName>
    <manufacturerName>QIAGEN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:23:58.131Z</lastUpdated>
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    <tradeName>DML 3000</tradeName>
    <deviceName>digene Microplate Luminometer 3000 (DML 3000)</deviceName>
    <manufacturerName>QIAGEN Sciences LLC</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>5000-00031</reference>
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    <lastUpdated>2026-07-01T16:22:51.491Z</lastUpdated>
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    <tradeName>GTQ-Cycler 96</tradeName>
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    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>1876820</reference>
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    <lastUpdated>2026-07-01T15:48:13.821Z</lastUpdated>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2017</reference>
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    <lastUpdated>2026-07-01T15:47:36.155Z</lastUpdated>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>7027001</reference>
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    <lastUpdated>2026-07-01T15:47:34.555Z</lastUpdated>
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