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    <deviceName>Xpress Flow QDot M100</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <reference>M-FLA-201-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:19:47.312Z</lastUpdated>
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    <tradeName>PS-10</tradeName>
    <deviceName>Sample Preparation System PS-10</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
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    <udiDi>06979824860104</udiDi>
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    <deviceName>Lymacyte Series Spectruml Flow Cytometers</deviceName>
    <manufacturerName>Shanghai Nokayun Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051537</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lymacyte（V-B-Y-R-UV-NR）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:30:03.868Z</lastUpdated>
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    <basicUdiDi>69803354801VN</basicUdiDi>
    <tradeName>Flow cytometer</tradeName>
    <deviceName>Flow cytometer</deviceName>
    <manufacturerName>Hangzhou Powclin Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000057159</manufacturerSrn>
    <authorisedRepresentativeName>Everbiz GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008964</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:31:40.138Z</lastUpdated>
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    <udiDi>06979824860098</udiDi>
    <basicUdiDi>697982486LSFSFC001EC</basicUdiDi>
    <tradeName>06979824860098</tradeName>
    <deviceName>Lymacyte Series Spectruml Flow Cytometers</deviceName>
    <manufacturerName>Shanghai Nokayun Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051537</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lymacyte（V-B-Y-R-UV）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:27:45.022Z</lastUpdated>
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    <udiDi>06977357001988</udiDi>
    <basicUdiDi>697735700197N4</basicUdiDi>
    <tradeName>Sperm-Cyto Flow Sperm Analyzer（LTSperisX3）</tradeName>
    <deviceName>Sperm-Cyto Flow Sperm Analyzer</deviceName>
    <manufacturerName>Chengdu Legend-Tec Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047100</manufacturerSrn>
    <authorisedRepresentativeName>GRZAN GROUP SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000039086</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:22:20.560Z</lastUpdated>
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    <udiDi>00810173655187</udiDi>
    <basicUdiDi>81649002Mplex-M100RS</basicUdiDi>
    <tradeName>00810173655187</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-FLA-202-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:08.570Z</lastUpdated>
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    <udiDi>06977357001995</udiDi>
    <basicUdiDi>697735700197N4</basicUdiDi>
    <tradeName>Sperm-Cyto Flow Sperm Analyzer (LTSperisX6)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chengdu Legend-Tec Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047100</manufacturerSrn>
    <authorisedRepresentativeName>GRZAN GROUP SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000039086</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>199</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T00:54:14.865Z</lastUpdated>
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    <udiDi>06977395751012</udiDi>
    <basicUdiDi>697739575002FJJ</basicUdiDi>
    <tradeName>Flow Cytometer(FlowCyte-B7)</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Biosino Medical Technology (Hefei) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041542</manufacturerSrn>
    <authorisedRepresentativeName>GRZAN GROUP SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000039086</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:32:55.814Z</lastUpdated>
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    <udiDi>06977395750015</udiDi>
    <basicUdiDi>697739575001FJF</basicUdiDi>
    <tradeName>Flow Cytometer(BioCyte-B5R3V7)</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Biosino Medical Technology (Hefei) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041542</manufacturerSrn>
    <authorisedRepresentativeName>GRZAN GROUP SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000039086</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:32:55.020Z</lastUpdated>
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    <udiDi>06977357002145</udiDi>
    <basicUdiDi>697735700214MB</basicUdiDi>
    <tradeName>Sheath Fluid（Model:A ；Package Specification：5L/bottle）</tradeName>
    <deviceName>Sheath Fluid</deviceName>
    <manufacturerName>Chengdu Legend-Tec Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047100</manufacturerSrn>
    <authorisedRepresentativeName>GRZAN GROUP SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000039086</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>214</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:29:44.836Z</lastUpdated>
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    <udiDi>06977357002084</udiDi>
    <basicUdiDi>697735700208MG</basicUdiDi>
    <tradeName>Erythrocyte Lysing Solution（Model:A ；Package Specification：15mL）</tradeName>
    <deviceName>Erythrocyte Lysing Solution</deviceName>
    <manufacturerName>Chengdu Legend-Tec Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047100</manufacturerSrn>
    <authorisedRepresentativeName>GRZAN GROUP SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000039086</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>208</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:29:43.058Z</lastUpdated>
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    <udiDi>06977357002060</udiDi>
    <basicUdiDi>697735700206MC</basicUdiDi>
    <tradeName>Sperm Acrosome Reaction Staining Kit（20 tests/kit）</tradeName>
    <deviceName>Sperm Acrosome Reaction Staining Kit</deviceName>
    <manufacturerName>Chengdu Legend-Tec Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047100</manufacturerSrn>
    <authorisedRepresentativeName>GRZAN GROUP SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000039086</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>206</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:29:40.667Z</lastUpdated>
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    <udiDi>06977357002046</udiDi>
    <basicUdiDi>697735700204M8</basicUdiDi>
    <tradeName>Sperm ROS Staining Kit  (Flow Cytometry)（20 tests/kit）</tradeName>
    <deviceName>Sperm ROS Staining Kit  (Flow Cytometry)</deviceName>
    <manufacturerName>Chengdu Legend-Tec Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047100</manufacturerSrn>
    <authorisedRepresentativeName>GRZAN GROUP SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000039086</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>204</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:29:39.060Z</lastUpdated>
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    <udiDi>06977357002022</udiDi>
    <basicUdiDi>697735700202M4</basicUdiDi>
    <tradeName>Sperm Mitochondrial Membrane Potential Staining Kit (JC-1, Flow Cytometry)（20 tests/kit）</tradeName>
    <deviceName>Sperm Mitochondrial Membrane Potential Staining Kit (JC-1, Flow Cytometry)</deviceName>
    <manufacturerName>Chengdu Legend-Tec Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047100</manufacturerSrn>
    <authorisedRepresentativeName>GRZAN GROUP SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000039086</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:29:38.262Z</lastUpdated>
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    <udiDi>06977357002008</udiDi>
    <basicUdiDi>697735700200LY</basicUdiDi>
    <tradeName>Sperm DNA Fragmentation Assay Kit（Flow Cytometry）(20 tests/kit)</tradeName>
    <deviceName>Sperm DNA Fragmentation Assay Kit（Flow Cytometry）</deviceName>
    <manufacturerName>Chengdu Legend-Tec Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047100</manufacturerSrn>
    <authorisedRepresentativeName>GRZAN GROUP SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000039086</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:29:36.654Z</lastUpdated>
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    <udiDi>06977357001971</udiDi>
    <basicUdiDi>697735700197N4</basicUdiDi>
    <tradeName>Sperm-Cyto Flow Sperm Analyzer</tradeName>
    <deviceName>Sperm-Cyto Flow Sperm Analyzer</deviceName>
    <manufacturerName>Chengdu Legend-Tec Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047100</manufacturerSrn>
    <authorisedRepresentativeName>GRZAN GROUP SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000039086</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LGSF0001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:29:34.264Z</lastUpdated>
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    <udiDi>06977357000103</udiDi>
    <basicUdiDi>697735700031LZ</basicUdiDi>
    <tradeName>Flow Cytometer(LegendCyto103)</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Chengdu Legend-Tec Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047100</manufacturerSrn>
    <authorisedRepresentativeName>GRZAN GROUP SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000039086</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:29:32.656Z</lastUpdated>
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    <basicUdiDi>69745018900A000301UM</basicUdiDi>
    <tradeName>NovoCyte Advanteon Dx Flow Cytometer</tradeName>
    <deviceName>NovoCyte Advanteon Dx Flow Cytometer</deviceName>
    <manufacturerName>Agilent Biosciences (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013066</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
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    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010260D, 2010261D, 2010262D,2010263D 2010260CE, 2010261CE, 2010262CE,2010263CE</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:20:47.314Z</lastUpdated>
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    <basicUdiDi>69745018900A000201UG</basicUdiDi>
    <tradeName>NovoCyte Quanteon Dx Flow Cytometer</tradeName>
    <deviceName>NovoCyte Quanteon Dx Flow Cytometer</deviceName>
    <manufacturerName>Agilent Biosciences (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013066</manufacturerSrn>
    <authorisedRepresentativeName>Agilent Technologies Denmark ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000001443</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:20:46.597Z</lastUpdated>
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