<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06976154090218</udiDi>
    <basicUdiDi>B-06976154090218</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Genegeo Diagnostics (Jiangsu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000052709</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200105000004</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:32:39.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976154090201</udiDi>
    <basicUdiDi>B-06976154090201</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Genegeo Diagnostics (Jiangsu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000052709</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200105000003</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:32:37.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976154090195</udiDi>
    <basicUdiDi>B-06976154090195</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Genegeo Diagnostics (Jiangsu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000052709</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200105000006</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:32:35.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976154090188</udiDi>
    <basicUdiDi>B-06976154090188</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Genegeo Diagnostics (Jiangsu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000052709</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200105000001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:32:34.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972168355626</udiDi>
    <basicUdiDi>B-06972168355626</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Maccura Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028087</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL9205003</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:34:05.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972168350300</udiDi>
    <basicUdiDi>B-06972168350300</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Maccura Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028087</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL9209003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:34:03.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972168350294</udiDi>
    <basicUdiDi>B-06972168350294</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Maccura Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028087</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL9207003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:34:02.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972168357538</udiDi>
    <basicUdiDi>69721683520019R</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Maccura Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028087</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL9207003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:35:34.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740730433</udiDi>
    <basicUdiDi>69357407IBH000004ND</basicUdiDi>
    <tradeName>BH-6180 5-Part-Diff Auto Hematology Analyzer</tradeName>
    <deviceName>5-Part-Diff Auto Hematology Analyzer</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:12.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230009420</udiDi>
    <basicUdiDi>361023ymz_h1500JQ</basicUdiDi>
    <tradeName>Yumizen H1500</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300102145</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:01.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230009437</udiDi>
    <basicUdiDi>361023ymz_h1500JQ</basicUdiDi>
    <tradeName>Yumizen H1500 (Yumizen SPS connectable)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300102146</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:01.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230009444</udiDi>
    <basicUdiDi>361023ymz_h2500JX</basicUdiDi>
    <tradeName>Yumizen H2500</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300102147</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:01.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230009451</udiDi>
    <basicUdiDi>361023ymz_h2500JX</basicUdiDi>
    <tradeName>Yumizen H2500 (Yumizen SPS connectable)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300102148</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:34:01.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202211423</udiDi>
    <basicUdiDi>B-06942202211423</basicUdiDi>
    <tradeName>Automatic Hematology Systerm</tradeName>
    <deviceName>Automatic Hematology Systerm</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-7200PLus</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:51:39.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941377301342</udiDi>
    <basicUdiDi>B-06941377301342</basicUdiDi>
    <tradeName>Auto Hematology Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XQ-0042-09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T04:16:31.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740735285</udiDi>
    <basicUdiDi>69357407IBH000004ND</basicUdiDi>
    <tradeName>BH-6580 5-Part-Diff Auto Hematology Analyzer</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:03:55.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972168357545</udiDi>
    <basicUdiDi>69721683520019R</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maccura Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028087</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL9205003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:37:24.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972168357552</udiDi>
    <basicUdiDi>69721683520019R</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maccura Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028087</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010102</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 120 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL9209003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:37:24.557Z</lastUpdated>
  </row>
</eudamedExport>