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<eudamedExport entity="devices">
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    <basicUdiDi>150995907DxFLEXVE</basicUdiDi>
    <tradeName>Beckman Coulter Flow cytometer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011854</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040180</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B67523</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:40:10.904Z</lastUpdated>
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    <udiDi>15099590787646</udiDi>
    <basicUdiDi>150995907DxFLEXVE</basicUdiDi>
    <tradeName>Beckman Coulter Flow cytometer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011854</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040180</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D08965</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:40:09.086Z</lastUpdated>
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  <row>
    <udiDi>15099590787707</udiDi>
    <basicUdiDi>150995907DxFLEXVE</basicUdiDi>
    <tradeName>Beckman Coulter Flow cytometer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beckman Coulter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011854</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202040180</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D08973</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T10:40:09.054Z</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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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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  <row>
    <udiDi>06935740731645</udiDi>
    <basicUdiDi>69357407IBF000001M5</basicUdiDi>
    <tradeName>BF-730 B4 Flow Cytometer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:02:17.034Z</lastUpdated>
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  <row>
    <udiDi>06935740731638</udiDi>
    <basicUdiDi>69357407IBF000001M5</basicUdiDi>
    <tradeName>BF-730 B5 Flow Cytometer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:02:15.978Z</lastUpdated>
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  <row>
    <udiDi>06935740731621</udiDi>
    <basicUdiDi>69357407IBF000001M5</basicUdiDi>
    <tradeName>BF-730 B4R2 Flow Cytometer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:02:13.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740731614</udiDi>
    <basicUdiDi>69357407IBF000001M5</basicUdiDi>
    <tradeName>BF-730 B5R2 Flow Cytometer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:02:12.225Z</lastUpdated>
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  <row>
    <udiDi>06935740731607</udiDi>
    <basicUdiDi>69357407IBF000001M5</basicUdiDi>
    <tradeName>BF-730 B5R3 Flow Cytometer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:02:11.029Z</lastUpdated>
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    <udiDi>06935740731591</udiDi>
    <basicUdiDi>69357407IBF000001M5</basicUdiDi>
    <tradeName>BF-730 B4R3V3 Flow Cytometer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:02:09.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740731584</udiDi>
    <basicUdiDi>69357407IBF000001M5</basicUdiDi>
    <tradeName>BF-730 B5R3V5 Flow Cytometer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202040103</emdnCode>
    <emdnDescription>CYTOFLOWMETERS - HIGH ROUTINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:02:08.647Z</lastUpdated>
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  <row>
    <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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    <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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