<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-2-269</udiDi>
    <basicUdiDi>B-2-269</basicUdiDi>
    <tradeName>URIT-2900Plus Automated Hematology Analyzer</tradeName>
    <deviceName>Automated 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:26:30.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413814240</udiDi>
    <basicUdiDi>69444138H30ProSP9</basicUdiDi>
    <tradeName>Hematology Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H31 Pro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:51:09.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413814257</udiDi>
    <basicUdiDi>69444138H30ProSP9</basicUdiDi>
    <tradeName>Hematology Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iH30 Pro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:51:09.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640142480464</udiDi>
    <basicUdiDi>B-07640142480464</basicUdiDi>
    <tradeName>Auto Hematology Analyzer MYTHIC 3CRP</tradeName>
    <deviceName>MYTHIC 3CRP</deviceName>
    <manufacturerName>Orphée SA</manufacturerName>
    <manufacturerSrn>CH-MF-000050926</manufacturerSrn>
    <authorisedRepresentativeName>PZ CORMAY Spółka Akcyjna</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000026245</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M3CRP</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:54:15.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640142480396</udiDi>
    <basicUdiDi>B-07640142480396</basicUdiDi>
    <tradeName>MYTHIC 18</tradeName>
    <deviceName>MYTHIC 18</deviceName>
    <manufacturerName>Orphée SA</manufacturerName>
    <manufacturerSrn>CH-MF-000050926</manufacturerSrn>
    <authorisedRepresentativeName>PZ CORMAY Spółka Akcyjna</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000026245</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M18OT</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:54:11.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976578180724</udiDi>
    <basicUdiDi>B-06976578180724</basicUdiDi>
    <tradeName>Auto 3-part Hematology Analyzer</tradeName>
    <deviceName>Auto 3-part Hematology Analyzer</deviceName>
    <manufacturerName>Wheisman Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045463</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>012090201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:54:01.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976578180694</udiDi>
    <basicUdiDi>B-06976578180694</basicUdiDi>
    <tradeName>Auto 3-part Hematology Analyzer</tradeName>
    <deviceName>Auto 3-part Hematology Analyzer</deviceName>
    <manufacturerName>Wheisman Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045463</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>012090301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:53:59.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976578180717</udiDi>
    <basicUdiDi>B-06976578180717</basicUdiDi>
    <tradeName>Auto 3-part Hematology Analyzer</tradeName>
    <deviceName>Auto 3-part Hematology Analyzer</deviceName>
    <manufacturerName>Wheisman Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045463</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>012090401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:53:57.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976578180700</udiDi>
    <basicUdiDi>B-06976578180700</basicUdiDi>
    <tradeName>Auto 3-part Hematology Analyzer</tradeName>
    <deviceName>Auto 3-part Hematology Analyzer</deviceName>
    <manufacturerName>Wheisman Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045463</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>012090104</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:53:57.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976578180687</udiDi>
    <basicUdiDi>B-06976578180687</basicUdiDi>
    <tradeName>Auto 5-part Hematology Analyzer</tradeName>
    <deviceName>Auto 5-part Hematology Analyzer</deviceName>
    <manufacturerName>Wheisman Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045463</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>012090901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:53:55.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976578180670</udiDi>
    <basicUdiDi>B-06976578180670</basicUdiDi>
    <tradeName>Auto 5-part Hematology Analyzer</tradeName>
    <deviceName>Auto 5-part Hematology Analyzer</deviceName>
    <manufacturerName>Wheisman Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045463</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>012090701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:53:40.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976578180571</udiDi>
    <basicUdiDi>B-06976578180571</basicUdiDi>
    <tradeName>Auto 5-part Hematology Analyzer</tradeName>
    <deviceName>Auto 5-part Hematology Analyzer</deviceName>
    <manufacturerName>Wheisman Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045463</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>012090804</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:53:29.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976578180090</udiDi>
    <basicUdiDi>B-06976578180090</basicUdiDi>
    <tradeName>Auto 5-part Hematology Analyzer</tradeName>
    <deviceName>Auto 5-part Hematology Analyzer</deviceName>
    <manufacturerName>Wheisman Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045463</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>012090502</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:53:28.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976117452718</udiDi>
    <basicUdiDi>B-06976117452718</basicUdiDi>
    <tradeName>Auto Hematology Analyzer</tradeName>
    <deviceName>Auto Hematology Analyzer</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>IVDD</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XQ-0112-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:30:40.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976117450301</udiDi>
    <basicUdiDi>B-06976117450301</basicUdiDi>
    <tradeName>Auto Hematology Analyzer</tradeName>
    <deviceName>Auto Hematology Analyzer</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>IVDD</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XQ-0076-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:28:16.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200368</udiDi>
    <basicUdiDi>59991062Icon3A2</basicUdiDi>
    <tradeName>Norma Icon-3 demo automated 3-part differential hematology analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NI30HD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:01.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200405</udiDi>
    <basicUdiDi>59991062i3LAB2K</basicUdiDi>
    <tradeName>Norma i3LAB demo automated 3-part differential hematology analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>NI31HD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:01.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200412</udiDi>
    <basicUdiDi>59991062Icon3A2</basicUdiDi>
    <tradeName>Hemolyzer® 3 NG automated 3-part differential hematology analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE3100</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:01.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883586334</udiDi>
    <basicUdiDi>5999883586A3XS</basicUdiDi>
    <tradeName>Aquarius 3 Hematology Analyzer</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>UNKNOWN</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A3N-1</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:22.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883586402</udiDi>
    <basicUdiDi>5999883586A38S9</basicUdiDi>
    <tradeName>Cell-Tech 380 Hematology Analyzer</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>UNKNOWN</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A380-CELLT</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:22.170Z</lastUpdated>
  </row>
</eudamedExport>