<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06945429021523</udiDi>
    <basicUdiDi>B-06945429021523</basicUdiDi>
    <tradeName>Neonatal Incubator</tradeName>
    <deviceName>Neonatal Incubator</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>MDD</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:45.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021516</udiDi>
    <basicUdiDi>B-06945429021516</basicUdiDi>
    <tradeName>Neonatal Incubator</tradeName>
    <deviceName>Neonatal Incubator</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>MDD</legislation>
    <emdnCode>Z1208040301</emdnCode>
    <emdnDescription>FIXED NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B6</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:43.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021509</udiDi>
    <basicUdiDi>B-06945429021509</basicUdiDi>
    <tradeName>Neonatal Incubator</tradeName>
    <deviceName>Neonatal Incubator</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>MDD</legislation>
    <emdnCode>Z1208040301</emdnCode>
    <emdnDescription>FIXED NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:39.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021486</udiDi>
    <basicUdiDi>69454290NV001QK</basicUdiDi>
    <tradeName>Neonatal Ventilator</tradeName>
    <deviceName>Neonatal 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>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NV6</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:35.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021479</udiDi>
    <basicUdiDi>69454290NV001QK</basicUdiDi>
    <tradeName>Neonatal Ventilator</tradeName>
    <deviceName>Neonatal 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>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NV9</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:33.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021462</udiDi>
    <basicUdiDi>69454290NV001QK</basicUdiDi>
    <tradeName>Neonatal Ventilator</tradeName>
    <deviceName>Neonatal 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>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NV7</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:29.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021455</udiDi>
    <basicUdiDi>69454290NV001QK</basicUdiDi>
    <tradeName>Neonatal Ventilator</tradeName>
    <deviceName>Neonatal 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>Z1203010503</emdnCode>
    <emdnDescription>NEONATAL/PAEDIATRIC PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NV8</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:27.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021448</udiDi>
    <basicUdiDi>B-06945429021448</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>MDD</legislation>
    <emdnCode>Z12030301</emdnCode>
    <emdnDescription>INFUSION PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:26.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021431</udiDi>
    <basicUdiDi>B-06945429021431</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>MDD</legislation>
    <emdnCode>Z12030302</emdnCode>
    <emdnDescription>SYRINGE PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M200A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:23.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021424</udiDi>
    <basicUdiDi>B-06945429021424</basicUdiDi>
    <tradeName>Infusion workstation</tradeName>
    <deviceName>Infusion workstation</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>MDD</legislation>
    <emdnCode>Z12030306</emdnCode>
    <emdnDescription>INFUSION AND SYRINGE PUMP CONTROL SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:20.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021417</udiDi>
    <basicUdiDi>69454290EV001MG</basicUdiDi>
    <tradeName>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>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V1A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:17.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021400</udiDi>
    <basicUdiDi>69454290EV001MG</basicUdiDi>
    <tradeName>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>Z1203010504</emdnCode>
    <emdnDescription>ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:16.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021394</udiDi>
    <basicUdiDi>69454290GV001N6</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>V3A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:14.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021387</udiDi>
    <basicUdiDi>69454290GV001N6</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>V3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:10.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021370</udiDi>
    <basicUdiDi>B-06945429021370</basicUdiDi>
    <tradeName>High Flow Heated Respiratory Humidifier</tradeName>
    <deviceName>High Flow Heated Respiratory Humidifier</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>MDD</legislation>
    <emdnCode>R060102</emdnCode>
    <emdnDescription>HOT NEBULISATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NF5</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:08.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021363</udiDi>
    <basicUdiDi>B-06945429021363</basicUdiDi>
    <tradeName>High Flow Heated Respiratory Humidifier</tradeName>
    <deviceName>High Flow Heated Respiratory Humidifier</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>MDD</legislation>
    <emdnCode>R060202</emdnCode>
    <emdnDescription>OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NF3</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:07.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021356</udiDi>
    <basicUdiDi>B-06945429021356</basicUdiDi>
    <tradeName>High Flow Heated Respiratory Humidifier</tradeName>
    <deviceName>High Flow Heated Respiratory Humidifier</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>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NF2</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:04.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021349</udiDi>
    <basicUdiDi>B-06945429021349</basicUdiDi>
    <tradeName>High Flow Heated Respiratory Humidifier</tradeName>
    <deviceName>High Flow Heated Respiratory Humidifier</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>MDD</legislation>
    <emdnCode>R060201</emdnCode>
    <emdnDescription>ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NF1</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:01.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021332</udiDi>
    <basicUdiDi>B-06945429021332</basicUdiDi>
    <tradeName>Sterile disposable electrode</tradeName>
    <deviceName>Sterile disposable electrode</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>MDD</legislation>
    <emdnCode>C020501</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>98ME01AC019</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:12:58.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021288</udiDi>
    <basicUdiDi>69454290CV001LS</basicUdiDi>
    <tradeName>Sterile Disposable Laryngoscope Blade</tradeName>
    <deviceName>Sterile Disposable Laryngoscope Blade</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>R9002</emdnCode>
    <emdnDescription>LARYNGOSCOPE BLADES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVL-3-1</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:12:57.494Z</lastUpdated>
  </row>
</eudamedExport>