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<eudamedExport entity="devices">
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    <udiDi>06945429021028</udiDi>
    <basicUdiDi>69454290AX001LJ</basicUdiDi>
    <tradeName>Anesthesia Machine</tradeName>
    <deviceName>Anesthesia Machine</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>Z1203010101</emdnCode>
    <emdnDescription>ANAESTHESIA DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AX-500A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:11:53.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021011</udiDi>
    <basicUdiDi>69454290AX001LJ</basicUdiDi>
    <tradeName>Anesthesia Machine</tradeName>
    <deviceName>Anesthesia Machine</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>Z1203010101</emdnCode>
    <emdnDescription>ANAESTHESIA DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AX-400A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:11:51.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021004</udiDi>
    <basicUdiDi>B-06945429021004</basicUdiDi>
    <tradeName>T piece Infant Resuscitation System</tradeName>
    <deviceName>T piece Infant Resuscitation 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>MDD</legislation>
    <emdnCode>R0599</emdnCode>
    <emdnDescription>RESPIRATORY DEVICES, SUCTION AND DILATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BQ70A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:11:50.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429020991</udiDi>
    <basicUdiDi>B-06945429020991</basicUdiDi>
    <tradeName>T piece Infant Resuscitation System</tradeName>
    <deviceName>T piece Infant Resuscitation 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>MDD</legislation>
    <emdnCode>R0599</emdnCode>
    <emdnDescription>RESPIRATORY DEVICES, SUCTION AND DILATION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BQ70</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:11:48.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429020953</udiDi>
    <basicUdiDi>B-06945429020953</basicUdiDi>
    <tradeName>Ceiling Pendant</tradeName>
    <deviceName>Ceiling Pendant</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>Z129007</emdnCode>
    <emdnDescription>HANGING UNITS FOR THE OPERATING ROOM AND INTENSIVE CARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D8</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:11:34.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429020915</udiDi>
    <basicUdiDi>69454290AG001GT</basicUdiDi>
    <tradeName>Anaesthetic Gas Scavenging System</tradeName>
    <deviceName>Anaesthetic Gas Scavenging 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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203010199</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGSS-H</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:11:25.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429020892</udiDi>
    <basicUdiDi>B-06945429020892</basicUdiDi>
    <tradeName>Infrared Ear thermometer</tradeName>
    <deviceName>Infrared Ear thermometer</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0301010201</emdnCode>
    <emdnDescription>CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRT10A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:11:19.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429020885</udiDi>
    <basicUdiDi>B-06945429020885</basicUdiDi>
    <tradeName>Infrared Ear thermometer</tradeName>
    <deviceName>Infrared Ear thermometer</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0301010201</emdnCode>
    <emdnDescription>CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRT10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:11:17.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429020878</udiDi>
    <basicUdiDi>B-06945429020878</basicUdiDi>
    <tradeName>Specialized Neonatal Monitor</tradeName>
    <deviceName>Specialized Neonatal Monitor</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Datalys 760</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:11:17.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429020861</udiDi>
    <basicUdiDi>B-06945429020861</basicUdiDi>
    <tradeName>Specialized Neonatal Monitor</tradeName>
    <deviceName>Specialized Neonatal Monitor</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C68</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:11:10.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429020854</udiDi>
    <basicUdiDi>B-06945429020854</basicUdiDi>
    <tradeName>Specialized Neonatal Monitor</tradeName>
    <deviceName>Specialized Neonatal Monitor</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C66</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:11:09.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429020847</udiDi>
    <basicUdiDi>B-06945429020847</basicUdiDi>
    <tradeName>Specialized Neonatal Monitor</tradeName>
    <deviceName>Specialized Neonatal Monitor</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C60</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:11:08.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429020779</udiDi>
    <basicUdiDi>B-06945429020779</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM300A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:10:52.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429020762</udiDi>
    <basicUdiDi>B-06945429020762</basicUdiDi>
    <tradeName>Electrocardiograph</tradeName>
    <deviceName>Electrocardiograph</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050301</emdnCode>
    <emdnDescription>GENERAL PURPOSE ELECTROCARDIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM300</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:10:51.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429020694</udiDi>
    <basicUdiDi>69454290MS001PK</basicUdiDi>
    <tradeName>Central Monitoring System</tradeName>
    <deviceName>Central Monitoring 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>Z1203020292</emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STAR8800</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:10:33.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429020687</udiDi>
    <basicUdiDi>B-06945429020687</basicUdiDi>
    <tradeName>Specialized Cardiovascular Monitor</tradeName>
    <deviceName>Specialized Cardiovascular Monitor</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C100B</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:10:32.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429020670</udiDi>
    <basicUdiDi>B-06945429020670</basicUdiDi>
    <tradeName>Specialized Cardiovascular Monitor</tradeName>
    <deviceName>Specialized Cardiovascular Monitor</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:10:26.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429020571</udiDi>
    <basicUdiDi>B-06945429020571</basicUdiDi>
    <tradeName>Fetal &amp; Maternal Monitor</tradeName>
    <deviceName>Fetal &amp; Maternal Monitor</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STAR5000H</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:10:04.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429020564</udiDi>
    <basicUdiDi>B-06945429020564</basicUdiDi>
    <tradeName>Fetal &amp; Maternal Monitor</tradeName>
    <deviceName>Fetal &amp; Maternal Monitor</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STAR5000F</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:10:03.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429020557</udiDi>
    <basicUdiDi>B-06945429020557</basicUdiDi>
    <tradeName>Fetal &amp; Maternal Monitor</tradeName>
    <deviceName>Fetal &amp; Maternal Monitor</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>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STAR5000E</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:09:57.399Z</lastUpdated>
  </row>
</eudamedExport>