<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06945429023589</udiDi>
    <basicUdiDi>69454290SL002Q6</basicUdiDi>
    <tradeName>Mobile Surgical Light</tradeName>
    <deviceName>Mobile Surgical Light</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>Z12010702</emdnCode>
    <emdnDescription>MOBILE SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L5-BM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:16:24.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023572</udiDi>
    <basicUdiDi>69454290SL002Q6</basicUdiDi>
    <tradeName>Mobile Surgical Light</tradeName>
    <deviceName>Mobile Surgical Light</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>Z12010702</emdnCode>
    <emdnDescription>MOBILE SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L5-AM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:16:22.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023565</udiDi>
    <basicUdiDi>69454290SL002Q6</basicUdiDi>
    <tradeName>Mobile Surgical Light</tradeName>
    <deviceName>Mobile Surgical Light</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>Z12010702</emdnCode>
    <emdnDescription>MOBILE SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L6-AM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:16:16.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023510</udiDi>
    <basicUdiDi>69454290IW003P7</basicUdiDi>
    <tradeName>Infusion Workstation System</tradeName>
    <deviceName>Infusion Workstation System</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>Z12030306</emdnCode>
    <emdnDescription>INFUSION AND SYRINGE PUMP CONTROL SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MX8900A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:16:15.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023503</udiDi>
    <basicUdiDi>69454290IW003P7</basicUdiDi>
    <tradeName>Infusion Workstation System</tradeName>
    <deviceName>Infusion Workstation System</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>Z12030306</emdnCode>
    <emdnDescription>INFUSION AND SYRINGE PUMP CONTROL SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MX8900</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:16:14.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023497</udiDi>
    <basicUdiDi>69454290IP002ML</basicUdiDi>
    <tradeName>Infusion Pump</tradeName>
    <deviceName>Infusion Pump</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>Z12030301</emdnCode>
    <emdnDescription>INFUSION PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME900A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:16:13.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023480</udiDi>
    <basicUdiDi>69454290IP002ML</basicUdiDi>
    <tradeName>Infusion Pump</tradeName>
    <deviceName>Infusion Pump</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>Z12030301</emdnCode>
    <emdnDescription>INFUSION PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME900</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:16:07.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023473</udiDi>
    <basicUdiDi>69454290IP004MQ</basicUdiDi>
    <tradeName>Infusion Pump</tradeName>
    <deviceName>Infusion Pump</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>Z12030301</emdnCode>
    <emdnDescription>INFUSION PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME660A</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:16:06.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023466</udiDi>
    <basicUdiDi>69454290IP004MQ</basicUdiDi>
    <tradeName>Infusion Pump</tradeName>
    <deviceName>Infusion Pump</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>Z12030301</emdnCode>
    <emdnDescription>INFUSION PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME660</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:16:05.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023459</udiDi>
    <basicUdiDi>69454290SP006RA</basicUdiDi>
    <tradeName>Syringe Pump</tradeName>
    <deviceName>Syringe Pump</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>Z12030302</emdnCode>
    <emdnDescription>SYRINGE PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M500B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:16:03.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023442</udiDi>
    <basicUdiDi>69454290SP006RA</basicUdiDi>
    <tradeName>Syringe Pump</tradeName>
    <deviceName>Syringe Pump</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>Z12030302</emdnCode>
    <emdnDescription>SYRINGE PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M500A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:15:57.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023428</udiDi>
    <basicUdiDi>69454290SP004R6</basicUdiDi>
    <tradeName>Syringe Pump</tradeName>
    <deviceName>Syringe Pump</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>Z12030302</emdnCode>
    <emdnDescription>SYRINGE PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M260</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:15:56.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023411</udiDi>
    <basicUdiDi>69454290SP002R2</basicUdiDi>
    <tradeName>Syringe Pump</tradeName>
    <deviceName>Syringe Pump</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>Z12030302</emdnCode>
    <emdnDescription>SYRINGE PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M800-TCI</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:15:55.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023404</udiDi>
    <basicUdiDi>69454290SP002R2</basicUdiDi>
    <tradeName>Syringe Pump</tradeName>
    <deviceName>Syringe Pump</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>Z12030302</emdnCode>
    <emdnDescription>SYRINGE PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M800A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:15:54.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023398</udiDi>
    <basicUdiDi>69454290SP002R2</basicUdiDi>
    <tradeName>Syringe Pump</tradeName>
    <deviceName>Syringe Pump</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>Z12030302</emdnCode>
    <emdnDescription>SYRINGE PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M800</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:15:48.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023381</udiDi>
    <basicUdiDi>69454290GV002N8</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>V8B</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:15:46.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023367</udiDi>
    <basicUdiDi>69454290GV002N8</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>V8</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:15:45.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023374</udiDi>
    <basicUdiDi>69454290GV002N8</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>V8A</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:15:44.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023350</udiDi>
    <basicUdiDi>69454290GV002N8</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>V6B</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:15:40.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023343</udiDi>
    <basicUdiDi>69454290GV002N8</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>V6A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:15:40.496Z</lastUpdated>
  </row>
</eudamedExport>