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<eudamedExport entity="devices">
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    <udiDi>06945429026351</udiDi>
    <basicUdiDi>B-06945429026351</basicUdiDi>
    <tradeName>Hematology Analyzer LYSE</tradeName>
    <deviceName>Hematology Analyzer LYSE</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:58.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026344</udiDi>
    <basicUdiDi>B-06945429026344</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CH8302CRP</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:56.555Z</lastUpdated>
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    <udiDi>06945429026337</udiDi>
    <basicUdiDi>B-06945429026337</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CH8301CRP</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:49.725Z</lastUpdated>
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    <udiDi>06945429026320</udiDi>
    <basicUdiDi>B-06945429026320</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CH8300CRP</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:48.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026313</udiDi>
    <basicUdiDi>B-06945429026313</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CH8312</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:46.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026306</udiDi>
    <basicUdiDi>B-06945429026306</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CH8311</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:45.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026290</udiDi>
    <basicUdiDi>B-06945429026290</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CH8310</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:39.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026283</udiDi>
    <basicUdiDi>B-06945429026283</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CH8302</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:37.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026276</udiDi>
    <basicUdiDi>B-06945429026276</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CH8301</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:36.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026269</udiDi>
    <basicUdiDi>B-06945429026269</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CH8300</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:35.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026252</udiDi>
    <basicUdiDi>B-06945429026252</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CH8502CRP</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:29.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026245</udiDi>
    <basicUdiDi>B-06945429026245</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CH8501CRP</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:27.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026238</udiDi>
    <basicUdiDi>B-06945429026238</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</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>CH8500CRP</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:26.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026221</udiDi>
    <basicUdiDi>B-06945429026221</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</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>CH8502</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:25.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026214</udiDi>
    <basicUdiDi>B-06945429026214</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</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>CH8501</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:18.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026207</udiDi>
    <basicUdiDi>B-06945429026207</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</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>CH8500</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:17.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026078</udiDi>
    <basicUdiDi>B-06945429026078</basicUdiDi>
    <tradeName>Full Range C-Reactive Protein（FR-CRP） Detection Kits (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Full Range C-Reactive Protein（FR-CRP） Detection Kits (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:15.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026061</udiDi>
    <basicUdiDi>B-06945429026061</basicUdiDi>
    <tradeName>Full Range C-Reactive Protein (FR-CRP) Assay Kit (Latex-enhanced Scatter Turbidimetry Method)</tradeName>
    <deviceName>Full Range C-Reactive Protein (FR-CRP) Assay Kit (Latex-enhanced Scatter Turbidimetry Method)</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Package:1×100T，Volume:16 mL</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:14.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026054</udiDi>
    <basicUdiDi>B-06945429026054</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</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>CH8602</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:08.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026047</udiDi>
    <basicUdiDi>B-06945429026047</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</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>CH8601</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:07.359Z</lastUpdated>
  </row>
</eudamedExport>