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<eudamedExport entity="devices">
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    <basicUdiDi>08600086663HERECLECC</basicUdiDi>
    <tradeName>HTI Cleaning Solution</tradeName>
    <deviceName>HTI Cleaning Solution</deviceName>
    <manufacturerName>High Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000036184</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010185</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00-52</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:52:36.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860008666369</udiDi>
    <basicUdiDi>08600086663HEREENZCV3</basicUdiDi>
    <tradeName>HTI Enzymatic Cleaner Concentrate</tradeName>
    <deviceName>HTI Enzymatic Cleaner Concentrate</deviceName>
    <manufacturerName>High Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000036184</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010185</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00-51</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:52:34.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860008666352</udiDi>
    <basicUdiDi>08600086663HEREENZE6</basicUdiDi>
    <tradeName>HTI Enzymatic Cleaner</tradeName>
    <deviceName>HTI Enzymatic Cleaner</deviceName>
    <manufacturerName>High Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000036184</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010185</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00-41</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:52:32.888Z</lastUpdated>
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  <row>
    <udiDi>00860008666345</udiDi>
    <basicUdiDi>08600086663HEREDETCS</basicUdiDi>
    <tradeName>HTI Detergent</tradeName>
    <deviceName>HTI Detergent</deviceName>
    <manufacturerName>High Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000036184</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010185</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00-31</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:52:31.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860008666321</udiDi>
    <basicUdiDi>08600086663HEREDILCN</basicUdiDi>
    <tradeName>HTI Diluent</tradeName>
    <deviceName>HTI Diluent</deviceName>
    <manufacturerName>High Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000036184</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010185</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:52:30.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860008666338</udiDi>
    <basicUdiDi>08600086663HERELYT1WP</basicUdiDi>
    <tradeName>HTI Lytic</tradeName>
    <deviceName>HTI Lytic Reagent</deviceName>
    <manufacturerName>High Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000036184</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010185</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-81</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:52:27.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860008666307</udiDi>
    <basicUdiDi>08600086663HEAR01T4</basicUdiDi>
    <tradeName>HTI MicroCC20-Plus</tradeName>
    <deviceName>HTI MicroCC20-Plus</deviceName>
    <manufacturerName>High Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000036184</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCC-2000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:52:26.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860008666314</udiDi>
    <basicUdiDi>08600086663HEAR02T6</basicUdiDi>
    <tradeName>HTI MicroCC25-Plus</tradeName>
    <deviceName>HTI MicroCC25-Plus</deviceName>
    <manufacturerName>High Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000036184</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCC-3000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:52:25.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844509000211</udiDi>
    <basicUdiDi>0844509012+MH</basicUdiDi>
    <tradeName>Para 12 Plus</tradeName>
    <deviceName>Para 12 Plus</deviceName>
    <manufacturerName>Streck</manufacturerName>
    <manufacturerSrn>US-MF-000013009</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010185</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>218924</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:20:34.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950334802396</udiDi>
    <basicUdiDi>69503348KT06RT</basicUdiDi>
    <tradeName>Auto Hematology Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KT-42</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:26:44.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950334802402</udiDi>
    <basicUdiDi>69503348KT06RT</basicUdiDi>
    <tradeName>Auto Hematology Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KT-40</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:26:44.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RT-7600SV</udiDi>
    <basicUdiDi>B-RT-7600SV</basicUdiDi>
    <tradeName>D-RT-7600SV</tradeName>
    <deviceName>Auto Hematology Analyzer</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT-7600</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:32:43.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Hemaray86FV</udiDi>
    <basicUdiDi>B-Hemaray86FV</basicUdiDi>
    <tradeName>D-Hemaray86FV</tradeName>
    <deviceName>Auto Hematology Analyzer</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Hemaray 86</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:00:18.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Hemaray83FP</udiDi>
    <basicUdiDi>B-Hemaray83FP</basicUdiDi>
    <tradeName>D-Hemaray83FP</tradeName>
    <deviceName>Auto Hematology Analyzer</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Hemaray 83</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:00:14.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Hema25XJ</udiDi>
    <basicUdiDi>B-Hema25XJ</basicUdiDi>
    <tradeName>NS Biotec blood cell counter</tradeName>
    <deviceName>Blood cell counter</deviceName>
    <manufacturerName>NS BIOTEC</manufacturerName>
    <manufacturerSrn>EG-MF-000032515</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>NS Biotec blood cell counter hema 25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:00:14.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Hema21XA</udiDi>
    <basicUdiDi>B-Hema21XA</basicUdiDi>
    <tradeName>NS Biotec blood cell counter</tradeName>
    <deviceName>Blood cell counter</deviceName>
    <manufacturerName>NS BIOTEC</manufacturerName>
    <manufacturerSrn>EG-MF-000032515</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>NS Biotec hema 21</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:00:13.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FRMF000041783ANALYZERJZ</udiDi>
    <basicUdiDi>B-FRMF000041783ANALYZERJZ</basicUdiDi>
    <tradeName>D-FRMF000041783ANALYZERJZ</tradeName>
    <deviceName>ONCOMEDICS ANALYZER</deviceName>
    <manufacturerName>Oncomedics SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000041783</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010282</emdnCode>
    <emdnDescription>LIMITED PANEL CELL COUNTING ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SW-ONCOANALYZ</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:46:44.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ESMF000044194ADSYJ</udiDi>
    <basicUdiDi>B-ESMF000044194ADSYJ</basicUdiDi>
    <tradeName>AdaptaSpot Smart</tradeName>
    <deviceName>AdaptaSpot Smart</deviceName>
    <manufacturerName>SPOTLAB SL</manufacturerName>
    <manufacturerSrn>ES-MF-000044194</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02020199</emdnCode>
    <emdnDescription>CELL COUNTING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPL-0001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:02:37.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C34520UV</udiDi>
    <basicUdiDi>B-C34520UV</basicUdiDi>
    <tradeName>UniCel DxH 690T Coulter Cellular Analysis System</tradeName>
    <deviceName>UniCel DxH 690T Coulter Cellular Analysis System</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C34520</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:53:34.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C11478UC</udiDi>
    <basicUdiDi>B-C11478UC</basicUdiDi>
    <tradeName>UniCel® DxH 900 Coulter® Cellular Analysis System</tradeName>
    <deviceName>UniCel® DxH 900 Coulter® Cellular Analysis System</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C11478</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:52:12.949Z</lastUpdated>
  </row>
</eudamedExport>