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<eudamedExport entity="devices">
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    <udiDi>06945429023084</udiDi>
    <basicUdiDi>69454290PM011PD</basicUdiDi>
    <tradeName>Multi-parameter Patient Monitor</tradeName>
    <deviceName>Multi-parameter Patient 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>MDR 2017/745</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N12A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:14:46.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023077</udiDi>
    <basicUdiDi>69454290PM011PD</basicUdiDi>
    <tradeName>Multi-parameter Patient Monitor</tradeName>
    <deviceName>Multi-parameter Patient 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>MDR 2017/745</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N12</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:14:44.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023060</udiDi>
    <basicUdiDi>69454290PM011PD</basicUdiDi>
    <tradeName>Multi-parameter Patient Monitor</tradeName>
    <deviceName>Multi-parameter Patient 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>MDR 2017/745</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N10C</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:14:43.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023053</udiDi>
    <basicUdiDi>69454290PM011PD</basicUdiDi>
    <tradeName>Multi-parameter Patient Monitor</tradeName>
    <deviceName>Multi-parameter Patient 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>MDR 2017/745</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N10A</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:14:40.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023046</udiDi>
    <basicUdiDi>69454290PM011PD</basicUdiDi>
    <tradeName>Multi-parameter Patient Monitor</tradeName>
    <deviceName>Multi-parameter Patient 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>MDR 2017/745</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N10</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:14:37.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023039</udiDi>
    <basicUdiDi>69454290DM003KA</basicUdiDi>
    <tradeName>06945429023039</tradeName>
    <deviceName>Defibrillator 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>MDR 2017/745</legislation>
    <emdnCode>Z12030502</emdnCode>
    <emdnDescription>MANUAL DEFIBRILLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S2A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:14:34.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429023022</udiDi>
    <basicUdiDi>69454290DM003KA</basicUdiDi>
    <tradeName>06945429023022</tradeName>
    <deviceName>Defibrillator 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>MDR 2017/745</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S2</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:14:33.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429022513</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-5-1</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:14:32.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429022506</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-1-1</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:14:27.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429022384</udiDi>
    <basicUdiDi>B-06945429022384</basicUdiDi>
    <tradeName>LED Surgical Light</tradeName>
    <deviceName>LED 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>MDD</legislation>
    <emdnCode>Z129004</emdnCode>
    <emdnDescription>LIGHT SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L6SCB</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:14:25.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429022377</udiDi>
    <basicUdiDi>B-06945429022377</basicUdiDi>
    <tradeName>LED Surgical Light</tradeName>
    <deviceName>LED 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>MDD</legislation>
    <emdnCode>Z129004</emdnCode>
    <emdnDescription>LIGHT SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L6SCA</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:14:23.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429022360</udiDi>
    <basicUdiDi>B-06945429022360</basicUdiDi>
    <tradeName>LED Surgical Light</tradeName>
    <deviceName>LED 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>MDD</legislation>
    <emdnCode>Z129004</emdnCode>
    <emdnDescription>LIGHT SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L6SC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:14:21.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021660</udiDi>
    <basicUdiDi>B-06945429021660</basicUdiDi>
    <tradeName>Medical Infant Bassinet</tradeName>
    <deviceName>Medical Infant Bassinet</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>Z120899</emdnCode>
    <emdnDescription>GYNAECOLOGY AND MATERNAL-INFANTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC-108</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:14:17.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021653</udiDi>
    <basicUdiDi>B-06945429021653</basicUdiDi>
    <tradeName>Medical Infant Bassinet</tradeName>
    <deviceName>Medical Infant Bassinet</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>Z120899</emdnCode>
    <emdnDescription>GYNAECOLOGY AND MATERNAL-INFANTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC-107</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:14:15.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021592</udiDi>
    <basicUdiDi>B-06945429021592</basicUdiDi>
    <tradeName>Video Laryngoscope</tradeName>
    <deviceName>Video Laryngoscope</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>Z12021004</emdnCode>
    <emdnDescription>VIDEO LARYNGOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVL-3</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:14:02.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021585</udiDi>
    <basicUdiDi>B-06945429021585</basicUdiDi>
    <tradeName>Video Laryngoscope</tradeName>
    <deviceName>Video Laryngoscope</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>Z12021004</emdnCode>
    <emdnDescription>VIDEO LARYNGOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVL-2</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:58.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021561</udiDi>
    <basicUdiDi>69454290VS001SN</basicUdiDi>
    <tradeName>Medical Air Compressor</tradeName>
    <deviceName>Medical Air Compressor</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>Z120309</emdnCode>
    <emdnDescription>MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-20</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:55.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021554</udiDi>
    <basicUdiDi>B-06945429021554</basicUdiDi>
    <tradeName>LED Surgical Light</tradeName>
    <deviceName>LED 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>MDD</legislation>
    <emdnCode>Z129004</emdnCode>
    <emdnDescription>LIGHT SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L6B</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:52.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021547</udiDi>
    <basicUdiDi>B-06945429021547</basicUdiDi>
    <tradeName>LED Surgical Light</tradeName>
    <deviceName>LED 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>MDD</legislation>
    <emdnCode>Z129004</emdnCode>
    <emdnDescription>LIGHT SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L6A</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:49.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021530</udiDi>
    <basicUdiDi>B-06945429021530</basicUdiDi>
    <tradeName>LED Surgical Light</tradeName>
    <deviceName>LED 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>MDD</legislation>
    <emdnCode>Z129004</emdnCode>
    <emdnDescription>LIGHT SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L6</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:13:46.719Z</lastUpdated>
  </row>
</eudamedExport>