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    <tradeName>Thermobrite</tradeName>
    <deviceName>Thermobrite</deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3800-004852-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:21:03.040Z</lastUpdated>
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    <udiDi>10888385000610</udiDi>
    <basicUdiDi>B-10888385000610</basicUdiDi>
    <tradeName>CellTracks AutoPrep System</tradeName>
    <deviceName>CellTracks AutoPrep System (Refurbished)</deviceName>
    <manufacturerName>Menarini Silicon Biosystems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042008</manufacturerSrn>
    <authorisedRepresentativeName>Menarini Silicon Biosystems S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000034891</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9541R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <udiDi>06956013926131</udiDi>
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    <tradeName>06956013926131</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AVE Science &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031214</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-26T09:18:25.420Z</lastUpdated>
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    <udiDi>00849832002086</udiDi>
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    <tradeName>ThermoBrite Slide Denaturation/ Hybridization System, S500-24</tradeName>
    <deviceName>Thermobrite</deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3800-004852-002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-26T03:36:21.015Z</lastUpdated>
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    <udiDi>00849832002093</udiDi>
    <basicUdiDi>849832026UX</basicUdiDi>
    <tradeName>ThermoBrite Slide Denaturation/ Hybridization System, 120V</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3800-004852-003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T03:36:10.963Z</lastUpdated>
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    <udiDi>00849832002109</udiDi>
    <basicUdiDi>849832026UX</basicUdiDi>
    <tradeName>ThermoBrite Slide Denaturation/ Hybridization System, S500-24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Richmond, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014614</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3800-004852-004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-26T03:36:10.869Z</lastUpdated>
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    <udiDi>06976193970090</udiDi>
    <basicUdiDi>697619397S067PK</basicUdiDi>
    <tradeName>06976193970090</tradeName>
    <deviceName>Microscopy Image Intelligent System</deviceName>
    <manufacturerName>Shenzhen Shengqiang Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047572</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQ-MIIS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-25T19:10:16.707Z</lastUpdated>
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    <udiDi>10888385000054</udiDi>
    <basicUdiDi>B-10888385000054</basicUdiDi>
    <tradeName>CellTracks Analyzer II</tradeName>
    <deviceName>CellTracks Analyzer II</deviceName>
    <manufacturerName>Menarini Silicon Biosystems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042008</manufacturerSrn>
    <authorisedRepresentativeName>Menarini Silicon Biosystems S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000034891</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9555</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:41:24.686Z</lastUpdated>
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    <udiDi>10888385000078</udiDi>
    <basicUdiDi>088838501003FK</basicUdiDi>
    <tradeName>CELLTRACKS AUTOPREP Instrument Buffer</tradeName>
    <deviceName>CELLTRACKS AUTOPREP Instrument Buffer</deviceName>
    <manufacturerName>Menarini Silicon Biosystems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042008</manufacturerSrn>
    <authorisedRepresentativeName>Menarini Silicon Biosystems S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000034891</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7901003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:02:10.484Z</lastUpdated>
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    <udiDi>06977698404875</udiDi>
    <basicUdiDi>697769840GKPD0846X</basicUdiDi>
    <tradeName>Biochemical and immunoassay analyzer</tradeName>
    <deviceName>Biochemical and immunoassay analyzer</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD084</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T18:59:58.807Z</lastUpdated>
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    <udiDi>06977698404769</udiDi>
    <basicUdiDi>697769840GKPD0856Z</basicUdiDi>
    <tradeName>Fully Auto POCT Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Fully Auto POCT Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD085</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T18:59:57.983Z</lastUpdated>
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    <udiDi>D-60501GB</udiDi>
    <basicUdiDi>B-60501GB</basicUdiDi>
    <tradeName>D-60501GB</tradeName>
    <deviceName>Fecal Workstation System</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:16:07.680Z</lastUpdated>
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    <udiDi>D-60201FU</udiDi>
    <basicUdiDi>B-60201FU</basicUdiDi>
    <tradeName>D-60201FU</tradeName>
    <deviceName>Sperm Quality Analyzer</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:16:02.059Z</lastUpdated>
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    <udiDi>D-60102FR</udiDi>
    <basicUdiDi>B-60102FR</basicUdiDi>
    <tradeName>D-60102FR</tradeName>
    <deviceName>Vaginal Secretion Analyzer</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:16:01.451Z</lastUpdated>
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    <udiDi>D-60101FP</udiDi>
    <basicUdiDi>B-60101FP</basicUdiDi>
    <tradeName>D-60101FP</tradeName>
    <deviceName>Vaginal Secretion Analyzer</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:15:58.833Z</lastUpdated>
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    <udiDi>06977698404592</udiDi>
    <basicUdiDi>697769840GKPD0906S</basicUdiDi>
    <tradeName>Electrolyte Analyzer</tradeName>
    <deviceName>Electrolyte Analyzer</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD090</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:22:52.584Z</lastUpdated>
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    <udiDi>06977568270159</udiDi>
    <basicUdiDi>697756827003R7</basicUdiDi>
    <tradeName>TMA</tradeName>
    <deviceName>Automated Tissue Microarrayer</deviceName>
    <manufacturerName>Guangzhou Naturn Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042263</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AUTO 12A；AUTO 24A；AUTO 5B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:22:29.375Z</lastUpdated>
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    <udiDi>06974677692490</udiDi>
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    <tradeName>Fully Automated Nucleic Acid Analyzer</tradeName>
    <deviceName>Fully Automated Nucleic Acid Analyzer</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:13:03.175Z</lastUpdated>
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    <udiDi>06974677690403</udiDi>
    <basicUdiDi>6974677690403J5</basicUdiDi>
    <tradeName>Nucleic Acid Isothermal Amplification Detection Analyzer</tradeName>
    <deviceName>Nucleic Acid Isothermal Amplification Detection Analyzer</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:12:50.380Z</lastUpdated>
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    <udiDi>06974677690397</udiDi>
    <basicUdiDi>6974677690397K3</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Purification Instrument</tradeName>
    <deviceName>Automatic Nucleic Acid Purification Instrument</deviceName>
    <manufacturerName>Shanghai BioGerm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018164</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:12:47.966Z</lastUpdated>
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