<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00858092006024</udiDi>
    <basicUdiDi>B-00858092006024</basicUdiDi>
    <tradeName>00858092006024</tradeName>
    <deviceName>QBC Autoread Plus Dry Hematology Analyzer</deviceName>
    <manufacturerName>Drucker Diagnostics</manufacturerName>
    <manufacturerSrn>US-MF-000031517</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>429576</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:35:00.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858092006000</udiDi>
    <basicUdiDi>B-00858092006000</basicUdiDi>
    <tradeName>00858092006000</tradeName>
    <deviceName>QBC STAR</deviceName>
    <manufacturerName>Drucker Diagnostics</manufacturerName>
    <manufacturerSrn>US-MF-000031517</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>429001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:34:57.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>05992795000387</udiDi>
    <basicUdiDi>599279503WM</basicUdiDi>
    <tradeName>D-Cell 360 + Hematology Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diagon Diagnosztikai Korlátolt Felelősségű Társaság</manufacturerName>
    <manufacturerSrn>HU-MF-000023582</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>g-dcell360+</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:09:15.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908026901009</udiDi>
    <basicUdiDi>8908026901YDCMS1JW</basicUdiDi>
    <tradeName>Yumizen D20</tradeName>
    <deviceName>Yumizen D20</deviceName>
    <manufacturerName>HORIBA India Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000049279</manufacturerSrn>
    <authorisedRepresentativeName>HORIBA ABX SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000368</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020199</emdnCode>
    <emdnDescription>CELL COUNTING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4000066860</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:09:12.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908018719049</udiDi>
    <basicUdiDi>8908018719049AS76PBS3Y</basicUdiDi>
    <tradeName>08908018719049</tradeName>
    <deviceName>Sigtuple Digital Pathology System with Peripheral Blood Smear Application</deviceName>
    <manufacturerName>SigTuple Technologies Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000024400</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020199</emdnCode>
    <emdnDescription>CELL COUNTING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Sig/Dev/0015</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:07:51.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908018719018</udiDi>
    <basicUdiDi>8908018719AI100SHONIT7S</basicUdiDi>
    <tradeName>AI100 with Shonit</tradeName>
    <deviceName>AI100 with Shonit</deviceName>
    <manufacturerName>SigTuple Technologies Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000024400</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020199</emdnCode>
    <emdnDescription>CELL COUNTING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Sig/Dev/0001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:07:50.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906194470013</udiDi>
    <basicUdiDi>890619447LM002EZ</basicUdiDi>
    <tradeName>LordsMed 5-Part Auto Hematology Analyzer</tradeName>
    <deviceName>5-Part Auto Hematology Analyzer</deviceName>
    <manufacturerName>Lord's Mark Industries Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000048403</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>LM002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:53:46.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906194470006</udiDi>
    <basicUdiDi>890619447LM001EX</basicUdiDi>
    <tradeName>LordsMed 3 Part Haematology Analyser</tradeName>
    <deviceName>3 Part Haematology Analyser</deviceName>
    <manufacturerName>Lord's Mark Industries Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000048403</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010202</emdnCode>
    <emdnDescription>SEMI-AUTOMATED HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LM001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:53:45.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>89061707101022</udiDi>
    <basicUdiDi>890617071AVMAXCOUNTK2</basicUdiDi>
    <tradeName>MAXCOUNT HMT 60P</tradeName>
    <deviceName>Auto Hematology Analyzer</deviceName>
    <manufacturerName>Avecon Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000040691</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</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>AVHMT 60P</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:50:23.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809898360027</udiDi>
    <basicUdiDi>880989836PBIA-100AME</basicUdiDi>
    <tradeName>08809898360027</tradeName>
    <deviceName>PBIA-100A</deviceName>
    <manufacturerName>UIMD Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000034633</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020199</emdnCode>
    <emdnDescription>CELL COUNTING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PBIA-100A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:03:19.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809898360003</udiDi>
    <basicUdiDi>880989836PBIA-12ACJ</basicUdiDi>
    <tradeName>08809898360003</tradeName>
    <deviceName>PBIA-12A</deviceName>
    <manufacturerName>UIMD Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000034633</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020199</emdnCode>
    <emdnDescription>CELL COUNTING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PBIA-12A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:03:15.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809317540993</udiDi>
    <basicUdiDi>880931754rWBCHT74</basicUdiDi>
    <tradeName>ADAM-rWBC HT</tradeName>
    <deviceName>ADAM-rWBC HT</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>ADAM-rWBC HT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:55:23.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809317540627</udiDi>
    <basicUdiDi>880931754ADAMIIFC</basicUdiDi>
    <tradeName>ADAMII</tradeName>
    <deviceName>ADAMII</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>ADAMII</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:55:23.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809317540252</udiDi>
    <basicUdiDi>880931754ADAMJC</basicUdiDi>
    <tradeName>ADAM-rWBC</tradeName>
    <deviceName>ADAM-rWBC</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>ADAM-rWBC</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:55:17.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806133010587</udiDi>
    <basicUdiDi>880613301058C9</basicUdiDi>
    <tradeName>CBChroma™</tradeName>
    <deviceName>CBChroma™</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>FPRR060</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:38:39.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720299985506</udiDi>
    <basicUdiDi>87202999855PC1009J</basicUdiDi>
    <tradeName>PC100</tradeName>
    <deviceName>PC100 Platelet Counter</deviceName>
    <manufacturerName>Dutch Medical Devices BV</manufacturerName>
    <manufacturerSrn>NL-MF-000011504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02020199</emdnCode>
    <emdnDescription>CELL COUNTING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PC100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:53:33.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156325271</udiDi>
    <basicUdiDi>8592156H7IN0301PL</basicUdiDi>
    <tradeName>H7100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</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>INS00087</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:25:54.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156140416</udiDi>
    <basicUdiDi>8592156HEIN0305WR</basicUdiDi>
    <tradeName>H560</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</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>INS00078</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:25:43.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156113212</udiDi>
    <basicUdiDi>8592156HEIN0303WM</basicUdiDi>
    <tradeName>ELite 580</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</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>INS00071</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:25:25.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156107426</udiDi>
    <basicUdiDi>8592156HEIN0304WP</basicUdiDi>
    <tradeName>H360</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010201</emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS00077</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:25:20.345Z</lastUpdated>
  </row>
</eudamedExport>