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<eudamedExport entity="devices">
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    <basicUdiDi>69357407IBHS000002DY</basicUdiDi>
    <tradeName>URIT D43 Probe Cleaner</tradeName>
    <deviceName>Probe Cleaner</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>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:03:40.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740723183</udiDi>
    <basicUdiDi>69357407IBHS000034ED</basicUdiDi>
    <tradeName>URIT 5L 11 Lyse</tradeName>
    <deviceName>Lyse</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>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:03:40.184Z</lastUpdated>
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  <row>
    <udiDi>06935740723152</udiDi>
    <basicUdiDi>69357407IBHS000006E8</basicUdiDi>
    <tradeName>URIT 5S 11 Sheath</tradeName>
    <deviceName>Sheath</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>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:03:38.502Z</lastUpdated>
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  <row>
    <udiDi>06935740718486</udiDi>
    <basicUdiDi>69357407IBHS000003E2</basicUdiDi>
    <tradeName>URIT L21 Lytic Reagent</tradeName>
    <deviceName>Lytic Reagent</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>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:03:31.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740703116</udiDi>
    <basicUdiDi>69357407IBHS000005E6</basicUdiDi>
    <tradeName>URIT 5D 11 Diluent</tradeName>
    <deviceName>Diluent</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>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:03:01.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740702966</udiDi>
    <basicUdiDi>69357407IBHS000001DW</basicUdiDi>
    <tradeName>URIT D41 Detergent</tradeName>
    <deviceName>Detergent</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>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:03:00.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>06262238886205</udiDi>
    <basicUdiDi>6262234DS-LYSERUA</basicUdiDi>
    <tradeName>4DS DANA</tradeName>
    <deviceName>Lyse 4DS Reagent for Hematology Analyzers (Sysmex compatible)</deviceName>
    <manufacturerName>Dana Tajhiz Aria</manufacturerName>
    <manufacturerSrn>IR-MF-000049659</manufacturerSrn>
    <authorisedRepresentativeName>Medisol Technologies S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000044726</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTA-SYS-81DS-42ml</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:33:29.457Z</lastUpdated>
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  <row>
    <udiDi>25999883586185</udiDi>
    <basicUdiDi>5999883586CLRWD</basicUdiDi>
    <tradeName>Diatro•Cleaner</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000020416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D5015</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T04:46:44.332Z</lastUpdated>
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  <row>
    <udiDi>03610230004579</udiDi>
    <basicUdiDi>361023minidil_lmgGN</basicUdiDi>
    <tradeName>ABX Minidil LMG 20L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0802020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:17.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230004609</udiDi>
    <basicUdiDi>361023diluentG8</basicUdiDi>
    <tradeName>ABX Diluent 20L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0901020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:17.921Z</lastUpdated>
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  <row>
    <udiDi>03610230004616</udiDi>
    <basicUdiDi>361023cleanerAK</basicUdiDi>
    <tradeName>ABX Cleaner 1L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0903010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:17.901Z</lastUpdated>
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  <row>
    <udiDi>03610230004623</udiDi>
    <basicUdiDi>361023cleanerAK</basicUdiDi>
    <tradeName>ABX Cleaner 0.5L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0903011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:17.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230004661</udiDi>
    <basicUdiDi>361023lyseX2</basicUdiDi>
    <tradeName>ABX Alphalyse 0.4L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0906004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:17.825Z</lastUpdated>
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  <row>
    <udiDi>03610230004692</udiDi>
    <basicUdiDi>361023lysebioQM</basicUdiDi>
    <tradeName>ABX Lysebio 0.4L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0906013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:17.786Z</lastUpdated>
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    <udiDi>03610230004708</udiDi>
    <basicUdiDi>361023lyseX2</basicUdiDi>
    <tradeName>ABX Alphalyse 360mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0906014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:17.763Z</lastUpdated>
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  <row>
    <udiDi>05391521421982</udiDi>
    <basicUdiDi>53915214FD50HR</basicUdiDi>
    <tradeName>sthemA FD-50</tradeName>
    <deviceName>sthemA FD-50</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01471</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:37.734Z</lastUpdated>
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  <row>
    <udiDi>05391521421999</udiDi>
    <basicUdiDi>53915214CL250AE</basicUdiDi>
    <tradeName>sthemA CL-250</tradeName>
    <deviceName>sthemA CL-250</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01424</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:35.334Z</lastUpdated>
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    <udiDi>05391521421890</udiDi>
    <basicUdiDi>53915214DL900069</basicUdiDi>
    <tradeName>sthemA DL-9000</tradeName>
    <deviceName>sthemA DL-9000</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01413</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:33.743Z</lastUpdated>
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    <udiDi>05391521421791</udiDi>
    <basicUdiDi>53915214FL50JZ</basicUdiDi>
    <tradeName>sthemA FL-50</tradeName>
    <deviceName>sthemA FL-50</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01422</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:33.063Z</lastUpdated>
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    <udiDi>05391521421814</udiDi>
    <basicUdiDi>53915214WB250F4</basicUdiDi>
    <tradeName>sthemA WB-250</tradeName>
    <deviceName>sthemA WB-250</deviceName>
    <manufacturerName>Tcoag ireland ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000027371</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01408</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:14:30.537Z</lastUpdated>
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