<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06903053082662</udiDi>
    <basicUdiDi>69449040AB70000173Z</basicUdiDi>
    <tradeName>M-6FM DYE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-047979-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:10.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908022609039</udiDi>
    <basicUdiDi>8908022609IVD0039U</basicUdiDi>
    <tradeName>HEMOLYNAC 310- MK-310WH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN INDIA PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000045419</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MK-310WH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:19:48.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908022609046</udiDi>
    <basicUdiDi>8908022609IVD0049W</basicUdiDi>
    <tradeName>HEMOLYNAC 510-MK-510WH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN INDIA PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000045419</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MK-510WH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:19:48.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908022609077</udiDi>
    <basicUdiDi>8908022609IVD0029S</basicUdiDi>
    <tradeName>Cleanac-3 MEK 620H</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN INDIA PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000045419</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MEK-620H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:19:48.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908022609084</udiDi>
    <basicUdiDi>8908022609IVD0029S</basicUdiDi>
    <tradeName>Cleanac 3-MEK 620H</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN INDIA PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000045419</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MEK-620H-HL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:19:48.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908022609091</udiDi>
    <basicUdiDi>8908022609IVD0029S</basicUdiDi>
    <tradeName>Cleanac-MEK 520H</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN INDIA PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000045419</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MEK-520H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:19:47.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908022609107</udiDi>
    <basicUdiDi>8908022609IVD0019Q</basicUdiDi>
    <tradeName>08908022609107</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN INDIA PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000045419</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MEK-641H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:19:47.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908022609237</udiDi>
    <basicUdiDi>8908022609IVD0029S</basicUdiDi>
    <tradeName>Cleanac 710-MK-710WH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN INDIA PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000045419</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MK-710WH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:19:47.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760173087266</udiDi>
    <basicUdiDi>376017308CLRT</basicUdiDi>
    <tradeName>IPO Cleaning</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO4020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:31.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760173087303</udiDi>
    <basicUdiDi>376017308CLRT</basicUdiDi>
    <tradeName>03760173087303</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2058/A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:31.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760173087389</udiDi>
    <basicUdiDi>376017308CLRT</basicUdiDi>
    <tradeName>Cleaning Solution for TIA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOLABO</manufacturerName>
    <manufacturerSrn>FR-MF-000001633</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO4000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:30.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617468806</udiDi>
    <basicUdiDi>69506174BL22024278</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer LD-6 Lysing Reagent</tradeName>
    <deviceName>Automatic Hematology Analyzer LD-6 Lysing Reagent</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2202242</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:49:30.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617468790</udiDi>
    <basicUdiDi>69506174BL22024278</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer LD-6 Lysing Reagent</tradeName>
    <deviceName>Automatic Hematology Analyzer LD-6 Lysing Reagent</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2201242</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:49:22.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617468783</udiDi>
    <basicUdiDi>69506174BL22024278</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer LD-6 Lysing Reagent</tradeName>
    <deviceName>Automatic Hematology Analyzer LD-6 Lysing Reagent</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2200242</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:49:21.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617468776</udiDi>
    <basicUdiDi>69506174BL22024278</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer LD-6 Lysing Reagent</tradeName>
    <deviceName>Automatic Hematology Analyzer LD-6 Lysing Reagent</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2201224</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:49:20.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617468660</udiDi>
    <basicUdiDi>69506174BL2202267A</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer LS-6 Lysing Reagent</tradeName>
    <deviceName>Automatic Hematology Analyzer LS-6 Lysing Reagent</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2203226</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:49:13.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617468653</udiDi>
    <basicUdiDi>69506174BL2202267A</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer LS-6 Lysing Reagent</tradeName>
    <deviceName>Automatic Hematology Analyzer LS-6 Lysing Reagent</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2202226</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:49:12.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617468639</udiDi>
    <basicUdiDi>69506174BL2202267A</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer LS-6 Lysing Reagent</tradeName>
    <deviceName>Automatic Hematology Analyzer LS-6 Lysing Reagent</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2201226</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:49:11.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617415367</udiDi>
    <basicUdiDi>69506174BL2200096Y</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer CC-5 Cell Clean A</tradeName>
    <deviceName>Automatic Hematology Analyzer CC-5 Cell Clean A</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2201009</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:31.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617415336</udiDi>
    <basicUdiDi>69506174BL2200086W</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer GD-5 Diluent A</tradeName>
    <deviceName>Automatic Hematology Analyzer GD-5 Diluent A</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL2201008</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:22.985Z</lastUpdated>
  </row>
</eudamedExport>