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    <udiDi>08908022609060</udiDi>
    <basicUdiDi>8908022609IVD0029S</basicUdiDi>
    <tradeName>Cleanac 3 MEK 620H</tradeName>
    <deviceName>Detergent</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-2L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:08:27.148Z</lastUpdated>
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    <udiDi>08908022609053</udiDi>
    <basicUdiDi>8908022609IVD0059Y</basicUdiDi>
    <tradeName>Celltac chemi Rinse solution -RN-410VH</tradeName>
    <deviceName>Rinse Solution</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>RN-410VH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:08:26.341Z</lastUpdated>
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    <udiDi>08908022609022</udiDi>
    <basicUdiDi>8908022609IVD0049W</basicUdiDi>
    <tradeName>HEMOLYNAC 5-MEK-910H</tradeName>
    <deviceName>Lysing Reagent</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-910H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:08:22.340Z</lastUpdated>
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    <udiDi>08908022609015</udiDi>
    <basicUdiDi>8908022609IVD0039U</basicUdiDi>
    <tradeName>HEMOLYNAC 3N- MEK 680H</tradeName>
    <deviceName>Lysing reagent</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 680H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:08:21.542Z</lastUpdated>
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    <udiDi>08908022609008</udiDi>
    <basicUdiDi>8908022609IVD0019Q</basicUdiDi>
    <tradeName>08908022609008</tradeName>
    <deviceName>Diluent</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-640H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:08:20.733Z</lastUpdated>
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  <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>
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    <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>
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    <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>
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