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<eudamedExport entity="devices">
  <row>
    <udiDi>06945429026030</udiDi>
    <basicUdiDi>B-06945429026030</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>CH8600</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:06.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026023</udiDi>
    <basicUdiDi>B-06945429026023</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>CH8602CRP</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:19:04.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026016</udiDi>
    <basicUdiDi>B-06945429026016</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>CH8601CRP</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:18:57.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026009</udiDi>
    <basicUdiDi>B-06945429026009</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>CH8600CRP</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:18:56.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429025996</udiDi>
    <basicUdiDi>69454290WS002T3</basicUdiDi>
    <tradeName>Medical Endoscopic Light Source</tradeName>
    <deviceName>Medical Endoscopic Light Source</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>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020402</emdnCode>
    <emdnDescription>LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LS-60</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:18:55.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429025156</udiDi>
    <basicUdiDi>69454290OT002QJ</basicUdiDi>
    <tradeName>Operating Table</tradeName>
    <deviceName>Operating Table</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>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011202</emdnCode>
    <emdnDescription>OPERATING TABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WE2A</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:18:54.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429025149</udiDi>
    <basicUdiDi>69454290OT002QJ</basicUdiDi>
    <tradeName>Operating Table</tradeName>
    <deviceName>Operating Table</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>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011202</emdnCode>
    <emdnDescription>OPERATING TABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WE2</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:18:46.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429025132</udiDi>
    <basicUdiDi>69454290OT002QJ</basicUdiDi>
    <tradeName>Operating Table</tradeName>
    <deviceName>Operating Table</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>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011202</emdnCode>
    <emdnDescription>OPERATING TABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WE1A</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:18:45.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429025125</udiDi>
    <basicUdiDi>69454290OT002QJ</basicUdiDi>
    <tradeName>Operating Table</tradeName>
    <deviceName>Operating Table</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>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011202</emdnCode>
    <emdnDescription>OPERATING TABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WE1</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:18:44.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429025071</udiDi>
    <basicUdiDi>69454290EV003ML</basicUdiDi>
    <tradeName>Product name: Emergency and Transport Ventilator</tradeName>
    <deviceName>Emergency and Transport Ventilator</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>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>EV2A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:18:33.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429025064</udiDi>
    <basicUdiDi>69454290EV003ML</basicUdiDi>
    <tradeName>Product name: Emergency and Transport Ventilator</tradeName>
    <deviceName>Emergency and Transport Ventilator</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>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>EV2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:18:26.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429025057</udiDi>
    <basicUdiDi>69454290EV002MJ</basicUdiDi>
    <tradeName>Emergency and Transport Ventilator</tradeName>
    <deviceName>Emergency and Transport Ventilator,Ventilator</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>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV3A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:18:25.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429025040</udiDi>
    <basicUdiDi>69454290EV002MJ</basicUdiDi>
    <tradeName>Emergency and Transport Ventilator</tradeName>
    <deviceName>Emergency and Transport Ventilator,Ventilator</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>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:18:24.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429025033</udiDi>
    <basicUdiDi>69454290EV002MJ</basicUdiDi>
    <tradeName>Emergency and transport ventilator</tradeName>
    <deviceName>Emergency and Transport Ventilator,Ventilator</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>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV5A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:18:22.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429025026</udiDi>
    <basicUdiDi>69454290EV002MJ</basicUdiDi>
    <tradeName>Emergency and transport ventilator</tradeName>
    <deviceName>Emergency and Transport Ventilator,Ventilator</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>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030104</emdnCode>
    <emdnDescription>PORTABLE PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV5</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:18:17.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429025019</udiDi>
    <basicUdiDi>69454290GV003NA</basicUdiDi>
    <tradeName>Ventilator</tradeName>
    <deviceName>Ventilator</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>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NV50B</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:18:14.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429025002</udiDi>
    <basicUdiDi>69454290GV003NA</basicUdiDi>
    <tradeName>Ventilator</tradeName>
    <deviceName>Ventilator</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>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NV50A</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:18:13.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429024999</udiDi>
    <basicUdiDi>69454290GV003NA</basicUdiDi>
    <tradeName>Ventilator</tradeName>
    <deviceName>Ventilator</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>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NV50</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:18:12.102Z</lastUpdated>
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  <row>
    <udiDi>06945429024982</udiDi>
    <basicUdiDi>69454290GV003NA</basicUdiDi>
    <tradeName>Ventilator</tradeName>
    <deviceName>Ventilator</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>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NV60B</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:18:06.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429024975</udiDi>
    <basicUdiDi>69454290GV003NA</basicUdiDi>
    <tradeName>Ventilator</tradeName>
    <deviceName>Ventilator</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>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NV60A</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:18:04.988Z</lastUpdated>
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</eudamedExport>