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<eudamedExport entity="devices">
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    <basicUdiDi>69745018900A000101UB</basicUdiDi>
    <tradeName>NovoCyte  Flow Cytometer</tradeName>
    <deviceName>NovoCyte 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>
    <reference>K2609-64000, K2609AA</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:20:45.008Z</lastUpdated>
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    <udiDi>06972825505388</udiDi>
    <basicUdiDi>697282550EZ03LD</basicUdiDi>
    <tradeName>06972825505388</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Shenzhen Wellgrow Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022880</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>EZ03 204P1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:12:26.961Z</lastUpdated>
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    <udiDi>06972227432442</udiDi>
    <basicUdiDi>697222743YQ002HW</basicUdiDi>
    <tradeName>Flow cytometry sample lyser</tradeName>
    <deviceName>Flow cytometry sample lyser</deviceName>
    <manufacturerName>Qingdao Raisecare Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033899</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>RaiseCyte Sampler</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:37:31.648Z</lastUpdated>
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    <udiDi>06972227432343</udiDi>
    <basicUdiDi>697222743YQ001HU</basicUdiDi>
    <tradeName>Flow Cytometer</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Qingdao Raisecare Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033899</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>RaiseCyte 2L6C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:37:30.049Z</lastUpdated>
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    <udiDi>06972227430493</udiDi>
    <basicUdiDi>697222743YQ006J6</basicUdiDi>
    <tradeName>RaiseCyte2L6C</tradeName>
    <deviceName>Flow Cytometer</deviceName>
    <manufacturerName>Qingdao Raisecare Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033899</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>RY01003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:37:27.643Z</lastUpdated>
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    <udiDi>06950996058117</udiDi>
    <basicUdiDi>69509960Mplex-M100DT</basicUdiDi>
    <tradeName>06950996058117</tradeName>
    <deviceName>Xpress Flow QDot M100</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-FLA-202-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:34:02.642Z</lastUpdated>
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    <udiDi>06950996045988</udiDi>
    <basicUdiDi>69509960Mplex-M1600H6</basicUdiDi>
    <tradeName>06950996045988</tradeName>
    <deviceName>Xpress Flow QDot M1600</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E1001C</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:33:53.383Z</lastUpdated>
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    <udiDi>06950996008259</udiDi>
    <basicUdiDi>69509960Mplex-M100DT</basicUdiDi>
    <tradeName>06950996008259</tradeName>
    <deviceName>Xpress Flow QDot M100</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-FLA-201-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:33:16.156Z</lastUpdated>
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    <udiDi>06977357002152</udiDi>
    <basicUdiDi>697735700214MB</basicUdiDi>
    <tradeName>Sheath Fluid（Model:B；Package Specification：5L/bottle）</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>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>215</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:49.957Z</lastUpdated>
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    <udiDi>06977357002169</udiDi>
    <basicUdiDi>697735700214MB</basicUdiDi>
    <tradeName>Sheath Fluid（Model:B；Package Specification：10L/bottle）</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>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>216</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:49.918Z</lastUpdated>
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    <udiDi>06977357002176</udiDi>
    <basicUdiDi>697735700214MB</basicUdiDi>
    <tradeName>Sheath Fluid（Model:B；Package Specification：15L/bottle）</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>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>217</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:49.868Z</lastUpdated>
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    <udiDi>06977357002183</udiDi>
    <basicUdiDi>697735700214MB</basicUdiDi>
    <tradeName>Sheath Fluid（Model:B；Package Specification：20L/bottle）</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>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>218</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:49.814Z</lastUpdated>
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  <row>
    <udiDi>06977357002015</udiDi>
    <basicUdiDi>697735700200LY</basicUdiDi>
    <tradeName>Sperm DNA Fragmentation Assay Kit（Flow Cytometry）（50 tests/kit）</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>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:34.149Z</lastUpdated>
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    <udiDi>06977357002039</udiDi>
    <basicUdiDi>697735700202M4</basicUdiDi>
    <tradeName>Sperm Mitochondrial Membrane Potential Staining Kit (JC-1, Flow Cytometry)（50 tests/kit）</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>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>203</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:22.323Z</lastUpdated>
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    <udiDi>06977357002077</udiDi>
    <basicUdiDi>697735700206MC</basicUdiDi>
    <tradeName>Sperm Acrosome Reaction Staining Kit（50 tests/kit）</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>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>207</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:06.388Z</lastUpdated>
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    <udiDi>06977357002053</udiDi>
    <basicUdiDi>697735700204M8</basicUdiDi>
    <tradeName>Sperm ROS Staining Kit  (Flow Cytometry)（50 tests/kit）</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>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>205</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:04.800Z</lastUpdated>
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    <udiDi>06977357002091</udiDi>
    <basicUdiDi>697735700208MG</basicUdiDi>
    <tradeName>Erythrocyte Lysing Solution（Model:A ；Package Specification：100mL）</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>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>209</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:03.061Z</lastUpdated>
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    <udiDi>06977357002107</udiDi>
    <basicUdiDi>697735700208MG</basicUdiDi>
    <tradeName>Erythrocyte Lysing Solution（Model:A ；Package Specification：250mL）</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>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:02.893Z</lastUpdated>
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    <udiDi>06977357002114</udiDi>
    <basicUdiDi>697735700208MG</basicUdiDi>
    <tradeName>Erythrocyte Lysing Solution（Model:B；Package Specification：15mL）</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>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:02.732Z</lastUpdated>
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    <udiDi>06977357002121</udiDi>
    <basicUdiDi>697735700208MG</basicUdiDi>
    <tradeName>Erythrocyte Lysing Solution（Model:B ；Package Specification：100mL）</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>
    <emdnCode>W02020499</emdnCode>
    <emdnDescription>FLOW CYTOMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:02.570Z</lastUpdated>
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