<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06944413813434</udiDi>
    <basicUdiDi>69444138H60SPG</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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H69S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:51:10.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905459004772</udiDi>
    <basicUdiDi>8905459HEMANA3K</basicUdiDi>
    <tradeName>Merilyzer CelQuant 5™ Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HMFCLQ-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:32.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905459004789</udiDi>
    <basicUdiDi>8905459HEMANA3K</basicUdiDi>
    <tradeName>Merilyzer CelQuant 5 Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HMFCLQ-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:32.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905459007063</udiDi>
    <basicUdiDi>8905459LUMQDL</basicUdiDi>
    <tradeName>Merilyzer LumiQuant™ LQ200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AALUQ-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:31.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905459007971</udiDi>
    <basicUdiDi>8905459HEMANA3K</basicUdiDi>
    <tradeName>Merilyzer CelQuant 5 Ultima</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HMFCLQ-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:31.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905459007988</udiDi>
    <basicUdiDi>8905459HEMANA3K</basicUdiDi>
    <tradeName>Merilyzer CelQuant 5 Ultima</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HMFCLQ-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:31.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640142480433</udiDi>
    <basicUdiDi>B-07640142480433</basicUdiDi>
    <tradeName>MYTHIC 70</tradeName>
    <deviceName>MYTHIC 70</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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M70AL</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:54:13.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640142480426</udiDi>
    <basicUdiDi>B-07640142480426</basicUdiDi>
    <tradeName>MYTHIC 60</tradeName>
    <deviceName>MYTHIC 60</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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M60OT</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:54:11.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978741670001</udiDi>
    <basicUdiDi>B-06978741670001</basicUdiDi>
    <tradeName>06978741670001</tradeName>
    <deviceName>Automatic 5-part Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen YC Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048035</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>HC-5000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:44:19.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698404097</udiDi>
    <basicUdiDi>B-06977698404097</basicUdiDi>
    <tradeName>Fully Auto 3-Part Hematology Analyzer</tradeName>
    <deviceName>Fully Auto 3-Part Hematology Analyzer</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</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>GKPD077</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:29:32.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698404042</udiDi>
    <basicUdiDi>B-06977698404042</basicUdiDi>
    <tradeName>Fully Auto 5-Part Hematology Analyzer</tradeName>
    <deviceName>Fully Auto 5-Part Hematology Analyzer</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</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>GKPD078</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:29:31.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976154091505</udiDi>
    <basicUdiDi>B-06976154091505</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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200106000015</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:32:52.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976154090287</udiDi>
    <basicUdiDi>B-06976154090287</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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200106000005</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:32:50.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976154090270</udiDi>
    <basicUdiDi>B-06976154090270</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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200106000002</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:32:48.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976154090263</udiDi>
    <basicUdiDi>B-06976154090263</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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200106000004</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:32:47.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976154090256</udiDi>
    <basicUdiDi>B-06976154090256</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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200106000003</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:32:46.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976154090249</udiDi>
    <basicUdiDi>B-06976154090249</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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20010600001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:32:43.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976154090232</udiDi>
    <basicUdiDi>B-06976154090232</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>2026-07-06T21:32:42.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976154090225</udiDi>
    <basicUdiDi>B-06976154090225</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>200105000005</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:32:41.323Z</lastUpdated>
  </row>
  <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>
</eudamedExport>