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    <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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>210001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:32:55.020Z</lastUpdated>
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    <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>
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    <legislation>IVDR 2017/746</legislation>
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    <lastUpdated>2026-07-02T19:29:44.836Z</lastUpdated>
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    <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>
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    <lastUpdated>2026-07-02T19:29:43.058Z</lastUpdated>
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    <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>
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    <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>
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    <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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    <udiDi>06975309200465</udiDi>
    <basicUdiDi>697530920G521E4</basicUdiDi>
    <tradeName>Flow Cytometer</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.LS.A2000A3</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:53.715Z</lastUpdated>
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    <udiDi>06975309200380</udiDi>
    <basicUdiDi>697530920038JU</basicUdiDi>
    <tradeName>06975309200380</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.LS.A5101E</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:52.132Z</lastUpdated>
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    <udiDi>06975309200373</udiDi>
    <basicUdiDi>697530920037JS</basicUdiDi>
    <tradeName>06975309200373</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.LS.A5108E</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:48.118Z</lastUpdated>
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    <udiDi>06975309200366</udiDi>
    <basicUdiDi>697530920036JQ</basicUdiDi>
    <tradeName>06975309200366</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.LS.A5107E</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:47.324Z</lastUpdated>
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    <udiDi>06975309200359</udiDi>
    <basicUdiDi>697530920035JN</basicUdiDi>
    <tradeName>06975309200359</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.LS.A5106E</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:46.537Z</lastUpdated>
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    <udiDi>06975309200342</udiDi>
    <basicUdiDi>697530920034JL</basicUdiDi>
    <tradeName>06975309200342</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.LS.A5105E</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:45.710Z</lastUpdated>
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    <udiDi>06975309200335</udiDi>
    <basicUdiDi>697530920033JJ</basicUdiDi>
    <tradeName>06975309200335</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.LS.A5104E</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:41.709Z</lastUpdated>
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    <udiDi>06975309200328</udiDi>
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    <tradeName>06975309200328</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.LS.A5103E</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:40.911Z</lastUpdated>
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    <tradeName>Flow Cytometer</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.LS.A5004E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:40.112Z</lastUpdated>
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    <tradeName>Flow Cytometer</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C.LS.A5003E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:39.316Z</lastUpdated>
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    <tradeName>06975309200014</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Beijing Challen Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023656</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LongCyte C1040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:36:35.309Z</lastUpdated>
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